Radiometer ABL800 blood gas analysers with software versions 6.14 through to Version 6.18. An in vitro diagnostic medical device (IVD). 의 리콜

Recall

RC-2018-RN-00926-1

Class II

2018-07-09

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00926-1

Radiometer has recently become aware that the abl800 series analysers could potentially induce a patient mix-up when “confirmation of demographics” is enabled as part of the query to aqure, radiance, or a his lis system. please note that the default setting for this function is ‘disabled’.The described error may potentially impact upon patient management as the physician may subject the patient to unnecessary treatment or erroneously withhold necessary treatment from the patient based upon the mixed-up of patient identification. in a worst-case scenario, where a critical parameter, such as k+ or po2, is interrogated, based upon a false clinical diagnosis inferred from the erroneous measurement, a critically ill patient may be subjected to lack of critical treatment.

Radiometer is advising that they are currently working on revising the software to correct this issue. Once release, a Radiometer representative will contact users to schedule a visit for the software upgrade. In the interim, users are requested to confirm if "Confirmation of Demographics" is disabled on their analysers. If disabled, the issue will not be experienced. If enabled, one of the two following counter-measures (CM) must be implemented: CM #1: Disable “Confirmation of Demographics” as follows: a. Logon to the analyzer. b. Select “Menu” > “Utilities” > “Setup” > “General Setup” > “Communications” > “Automatic Data Request” c. Remove the checkmark for “Confirm requested data”, if present. d. Select “Close”. Or CM #2: If disabling the “Confirmation of Demographics” (CM #1) is not possible due to e.g. internal procedures, instruct all operators of the analyser(s) to not introduce a new sample when the menu for “Confirmation of Demographics” is being displayed.