TRUEtrack and TRUEbalance Blood Glucose Monitoring System 의 안전성 경고

Safety alert

2013-10-31

2013-10-31

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20131031.html

Medical device safety alert: nipro diagnostics truetrack and truebalance blood glucose monitoring system the medicines and healthcare products regulatory agency (mhra), united kingdom has posted a field safety notice concerning two models of blood glucose monitoring systems: i) truetrack (private label: wellion smart system, stada gluco check); & ii) truebalance (private label: wellion smart system 2), manufactured by nipro diagnostics. during a specific reconfiguration process in the company’s establishment in florida, usa where unused blood glucose meters in their original packaging are returned from customers and reconfigured with the appropriate unit of measure for a different geographic market to which they will be shipped, the unit of measure was set incorrectly on a small subset of reconfigured truebalance and truetrack meters. as the result of a process error in the reconfiguration process, certain meters may display: mmol/l as the unit of measure instead of mg/dl; or mg/dl as the unit of measure instead of mmol/l. for meters with incorrect mmol/l unit: in the event the user is unable to identify that the meter is displaying an incorrect unit of measure (mmol/l), the user may interpret the reading as abnormally low, depending on the user’s actual blood glucose value. based on this sequence of events, the user will not over medicate but may unknowingly remain in a hyperglycemic state. for meters with incorrect mg/dl unit: in the event the user is unable to identify that the meter is displaying an incorrect unit of measure (mg/dl), the user may interpret the reading as higher or much higher than expected, depending on the user’s actual blood glucose value. based on this sequence of events, the insulin user may over medicate and unknowingly remain in a hypoglycemic state or possibly over medicate, which may result in death or irreversible harm. there are no reports of adverse events or injury to date. users are advised to contact their supplier to see if their products are affected and the necessary actions for returning the devices if affected. according to the manufacturer, the affected products were not distributed in hong kong. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con326483 posted on 31 october 2013.