Important Safety Alerts

The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom (UK) issued a medical device alert and a press release concerning GlucoMen LX Sensor blood glucose test strips 50 count (product code 38877). They are used with the GlucoMen LX and GlucoMen LX PLUS meter and they are manufactured by Menarini in Italy. The affected lot numbers are 3212214249 (expiry date 31 Aug 2014) and 3212219249 (expiry date 31 Aug 2014).

According to the MHRA, the affected lots have been contaminated during manufacture, and may give an overestimation of blood glucose levels, potentially resulting in inappropriate insulin administration. There is currently no evidence that UK patients have been affected.

The MHRA provides the following advice to the affected users/ healthcare personnel:

• Identify and quarantine affected lots.
• Identify patients using these meters and advise them that they should return and not use strips from the affected lots.
• Ensure that users who return strips from the affected lots can continue to monitor their blood glucose.
• Contact Menarini to arrange the return of any strips from the affected lots.

According to the local supplier, the affected products were not distributed in Hong Kong.

For details, please visit the following MHRA website:
http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON305472
http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON303150

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 15 August 2013