Events

One Touch Ping Glucose Monitoring System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Animas Corporation 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    49475
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0283-2009
  • 사례 시작날짜
    2008-08-04
  • 사례 출판 날짜
    2008-11-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-11-12
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73524
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Insulin Infusion Pump - Product Code LZG
  • 원인
    Display old, inaccurate values for bolus amount delivered and amount of planned bolus totals.
  • 조치
    On 8/6/08, the recalling firm telephoned all users to inform them of problem and the need to return the system.

Device

One Touch Ping Glucose Monitoring System
  • 모델명 / 제조번호(시리얼번호)
    Part numbers: 100-430-00, 100-431-00, 100-432-00, 100-434-00, and 100-435-00. Serial numbers: 01-02000-15, 02-02001-15, 03-02002-15, 04-02003-15, 04-02010-15, 05-02004-15, 05-02011-15, 06-02012-15, 06-02100-15, 07-02013-15, 07-02101-15, 08-02007-15, 08-02102-15, 09-02008-15, 09-02110-15, 10-02009-15, 10-02104-15, 10-02111-15, 11-02112-15, 12-02032-15, 12-02106-15, 12-02113-15, 12-02120-15, 13-02033-15, 13-02040-15, 13-02107-15, 13-02121-15, 13-02202-15, 14-02027-15, 14-02034-15, 14-02108-15, 14-02203-15, 14-02210-15, 15-02028-15, 15-02035-15, 15-02042-15, 15-02123-15, 15-02204-15, 16-02029-15, 16-02036-15, 16-02050-15, 16-02117-15, 16-02124-15, 16-02131-15, 16-02205-15, 16-02300-15, 17-02037-15, 17-02051-15, 17-02118-15, 17-02132-15, 17-02213-15, 17-02220-15, 18-02038-15, 18-02126-15, 18-02140-15, 18-02221-15, 19-02039-15, 19-02053-15, 19-02060-15, 19-02127-15, 19-02208-15, 19-02222-15, 20-02047-15, 20-02054-15, 20-02142-15, 20-02209-15, 20-02216-15, 20-02223-15, 20-02304-15, 21-02048-15, 21-02129-15, 21-02136-15, 21-02143-15, 21-02150-15, 21-02217-15, 21-02224-15, 21-02231-15, 22-02049-15, 22-02056-15, 22-02063-15, 22-02144-15, 22-02151-15, 22-02225-15, 22-02232-15, 23-02057-15, 23-02071-15, 23-02152-15, 23-02219-15, 23-02233-15, 23-02240-15, 24-02058-15, 24-02065-15, 24-02072-15, 24-02139-15, 24-02160-15, 24-02241-15, 25-02059-15, 25-02066-15, 25-02080-15, 25-02147-15, 25-02228-15, 25-02235-15, 26-02148-15, 26-02155-15, 26-02162-15, 26-02236-15, 26-02243-15, 26-02250-15, 26-02331-15, 27-02149-15, 27-02156-15, 27-02163-15, 27-02237-15, 27-02244-15,  28-02076-15, 28-02090-15, 28-02157-15, 28-02164-15, 28-02171-15, 28-02245-15, 28-02319-15, 28-02333-15, 29-02091-15, 29-02158-15, 29-02172-15, 29-02246-15, 29-02253-15, 29-02260-15, 30-02092-15, 30-02166-15,  30-02173-15, 30-02180-15, 30-02247-15, 30-02254-15, 30-02261-15, 30-02342-15, 31-02093-15, 31-02167-15, 31-02248-15, 31-02255-15, 31-02262-15, 31-02336-15, 32-02094-15, 32-02168-15, 32-02175-15, 32-02256-15, 32-02263-15, 32-02351-15, 33-02088-15, 33-02169-15, 33-02176-15, 33-02190-15, 33-02345-15, 34-02096-15, 34-02177-15, 34-02184-15, 34-02191-15, 34-02258-15, 35-02178-15, 35-02185-15, 35-02192-15, 35-02259-15, 36-02098-15, 36-02186-15, 36-02193-15, 36-02348-15, 37-02099-15, 37-02195-15, 39-02189-15, 39-02196-15, 40-01901-15, 40-02197-15, 41-02198-15, 42-01910-15, 42-02199-15, 43-01911-15, 44-01912-15, 45-01906-15, 45-01913-15, 45-01920-15, 48-01909-15, 49-01924-15, 49-01931-15, 50-01918-15, 50-01925-15, 51-01926-15, 51-01940-15, 52-01927-15, 52-01934-15, 52-01941-15, 53-01928-15, 53-01942-15, 54-01936-15, 54-01943-15, 54-01950-15, 55-01951-15, 56-01864-15, 56-01938-15, 56-01952-15, 57-01939-15, 57-01946-15, 57-01953-15, 57-01960-15, 58-01866-15, 58-01873-15, 58-01947-15, 58-01961-15, 59-01874-15, 59-01948-15, 59-01948-15, 60-01868-15, 60-01882-15, 60-01949-15, 60-01963-15, 60-01970-15, 61-01869-15, 61-01876-15, 61-01883-15, 61-01890-15, 61-01957-15, 62-01877-15, 62-01884-15, 62-01891-15, 62-01958-15, 63-01885-15, 63-01892-15, 63-01959-15, 63-01973-15, 64-01886-15, 64-01893-15, 64-01974-15, 64-01981-15, 65-01887-15, 67-01889-15, 67-01896-15, 67-01991-15, 68-01897-15, 68-01985-15, 68-01992-15, 69-01898-15, 69-01979-15, 69-01993-15, 70-01899-15, 70-01987-15, 70-01994-15, 71-01995-15, 72-01996-15, 73-01997-15, 74-01998-15, and 75-01999-15.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    One Touch Ping Glucose Monitoring System || Combines the functionality of OneTouch(R) Ping (TM) Insulin Pump and a OneTouch(R) Ping (TM) Meter Remote through radio frequency (RF) communication. Together, they provide an option to help make insulin delivery more discreet and flexible. Also, allows the most recent blood glucose results from the OneTouch(R) Ping (TM) Meter Remote to be automatically entered into bolus insulin calculations to cover carbohydrates in food or to correct for a high blood glucose level.
  • Manufacturer
    Animas Corporation

Manufacturer

Animas Corporation
  • 제조사 주소
    Animas Corporation, 200 Lawrence Dr, West Chester PA 19380
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA