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The Department of Health (DH) today (November 2) drew public attention to Abbott Diabetes Care's recall of its FreeStyle InsuLinx Blood Glucose Monitoring System (the System) in the United Kingdom. A software error in certain lots may lead to the resetting of the System, including its recommending the use of "0" units of insulin even if the blood glucose readings are high, thereby creating a situation whereby users may mismanage their diabetes treatment.
A DH spokesman revealed that the Department came to know of the incident through its routine surveillance scheme on medical devices. The System is meant to be used by diabetic patients for self-monitoring their blood glucose status and is a device which can also offer suggestions on insulin doses required.
According to the report filed by Abbott to the UK authorities, the defect was detected through its ongoing internal quality process. When the "Backup" and "Restore" functions of the FreeStyle Auto-Assist Software inside the System are used for the first time, certain settings in the System may be reset.
"Besides the insulin calculator values, affected ones can include sound preferences, notes, reminders and weekly messages. Neither is the blood glucose reading displayed nor the data stored involved," the spokesman said.
Abbott's investigation pointed out that the defect is limited to certain lots and serial number of Systems of a specific part number, with details as follows:
* Part Number: 71148-70
* Lot Number: 01R139F, 01R146F, 02R145F, 02R153F and 03R153F
* Description: FreeStyle InsuLinx Blood Glucose Monitoring System
* Potentially Affected Meter Serial Number Range: All Serial Numbers where the beginning seven characters fall within the range: JAMR128-JAMR252
Preliminary enquiry with the local supplier, Abbott Laboratories Limited, revealed that the FreeStyle InsuLinx System concerned is mainly distributed in Europe and has not been launched in Hong Kong.
"Although the System is not marketed in Hong Kong and we have no record of related adverse events here or overseas, the fact that there may be occasional patients in the territory who have somehow obtained the devices from abroad and the dreaded consequences together justify a public alert, in our opinion," the spokesman remarked.
"People who have devices belonging to the failed lots should contact Abbott Laboratories Limited for advice and follow-up," the spokesman urged. The company has set up a hotline at phone 2806 4488 to answer related enquiries.
Meanwhile, the DH has informed all public and private hospitals, related medical associations and healthcare professionals about the matter and also advised them to stay vigilant.
The spokesman further advised that those customers who have used the said product and are either feeling unwell or in doubt should consult their healthcare professionals for advice as soon as possible.
Ends/Wednesday, November 2, 2011
Issued at HKT 17:03
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