The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom has posted a field safety notice concerning G4 PLATINUM Replacement Receiver Kit (Model no.: STR-GL-001) manufactured by Dexcom Inc.
The affected products can be identified by the following serial numbers: SM23470992, SM23471039, SM23471062, SM23471144, SM23471148. The affected lot number is 5045847.
Dexcom G4 PLATINUM Replacement Receiver Kits (STR-GL-001, Lot 5045847) sent to Advanced Therapeutics United Kingdom are not affixed with a CE Mark and are not approved for distribution within the European Economic Area (EEA). Five units were shipped from Dexcom's manufacturing site in San Diego, CA, USA to Advanced Therapeutics, UK on 24 October 2012. The subject devices accept and display glucose measurements in mg/dL, whereas devices approved for use in the UK must display glucose measurement in mmol/L.
This product nonconformance has no effect on safety and/or patient health. There are no reports of illness or injury associated with this issue. There is no hazard involved as the receivers in the kits use mg/dL as the unit of measure for blood glucose rather than mmol/L. The device requires entry of blood glucose readings from a blood glucose meter for calibration and start up prior to use. The subject devices will not accept the mmol/L blood glucose meter measurement ranges, and would not be able to calibrate at start-up, eliminating the potential for false values to be displayed. In addition, the end user is extremely likely to notice the incorrect unit of measure for blood glucose prior to an attempt to use the device.
The manufacturer advises that further distribution or use of any remaining product affected by this recall should cease immediately. All affected products must be quarantined and returned to the manufacturer.
For details, please refer to the MHRA website:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/ fieldsafetynotices/CON205394
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 27 November 2012