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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 089 10 11 000
Date submitted: 10/30/2011
Manufacturer:HemoCue A B
Device Type:Analyser, blood glucose, HemoCue Glucose 201+ system
Description:Analyser, Blood, Glucose
Medical Device Identifier:HemoCue Glucose 201+ system, Model no.: 120710, 120711, 120712, 120713, 120714, 120715, 120716, 120717, 120718, 120719, 120721, 120722, 120723-R, 120751, 120752 Software version: 106 and lower
Reason of Field Safety Corrective Action:Incidents have been reported to HemoCue AB in which the HemoCue Glucose 201+ system with software version 106 and lower has showed 0.0 mmol/L (0 mg/dL) instead of indicating that the blood glucose result was high and outside the measuring range of the system. The problem is related to a known software bug in the HemoCue Glucose 201+ analyzers manufactured before 2006.
Remedy Action:Customers with instruments produced before 2006-12-21 and with a software version of 106 or lower will again be informed about the problem. Together with the information an addendum to the operating manual will be enclosed. The customer is asked to attach the addendum to the operating manual. This is to ensure that all users of the HemoCue Glucose 201+ system have the needed information available. The customers are also offered an upgrade of the software.
Athorized Representative/Importer/Distributor:Raez Environmental System & Advanced Technologies, Riyadh, (01) 4782295
Report Source:NCAR
Source Ref. Number:SE-2011-10-25-043
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Technical Letter HemoCue Glucose 201+ analyzer.pdf