Medical Device Alert - FreeStyle Libre 2 Sensors
A medical device alert has been issued by the Medicines & Healthcare products Regulatory Agency (MHRA) for FreeStyle Libre 2 glucose sensors.
MHRA reference: 5028007
Company name: Abbott
Product description: FreeStyle Libre 2 sensors
Details of the affected batch: Lot KTP005061
Brief description of problem:
Abbott has recently identified that certain FreeStyle Libre® 2 sensors from lot KTP005061 may provide erroneously high glucose readings. For example, customers’ sensor glucose reading may be high and out of their target range while their actual glucose levels may be below or within target range.
Advice to Healthcare Professionals:
- In the next few days, an Abbott sales representative will visit pharmacies to assist checking inventories to identify impacted sensors. They will arrange free of charge replacement and collection of any impacted sensors.
- In the meantime, pharmacies may wish to visit www.FreeStyleConfirm.com and enter the sensor serial number of the affected batch to confirm any affected sensors in stock.
- Do not dispense any affected sensors they will be replaced free of charge when the local Abbott sales representative visits.
- Advise any patients that may have had dispensed sensors from lot number KTP005061, they should also visit www.FreeStyleConfirm.com and enter the sensor serial number.
- If any patient is currently using the FreeStyle Libre® 2 system and wearing an affected sensor, please instruct them to immediately discontinue use.
- Please communicate this issue to any customers whom have been supplied FreeStyle Libre® 2 sensors from lot KTP005061.
- Patients will be sent replacements for any affected sensor(s), including a mailing kit to return any affected sensor(s) to Abbott.
- While waiting for a replacement Sensor, patients can continue to use sensors that are not affected and can use the built-in blood glucose meter in the FreeStyle Libre® 2 reader to check glucose at any time.
Advice to Patients:
- If any patient is currently using the FreeStyle Libre® 2 system and wearing an affected sensor, they should immediately discontinue use.
- Patients will be sent replacements for any affected sensor(s), including a mailing kit to return any affected sensor(s) to Abbott.
- While waiting for a replacement Sensor, patients can continue to use sensors that are not affected and can use the built-in blood glucose meter in the FreeStyle Libre® 2 reader to check glucose at any time.
Company contacts for further information:
Abbott Customer Service 0800 170 1177