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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 053 10 17 000
Date submitted: 10/16/2017
Manufacturer:Medtronic
Device Type:CareLink iPro Therapy Management Software
Description:Glucose monitoring system
Medical Device Identifier:All Serial# for (model: MMT-7340)
Reason of Field Safety Corrective Action:Due to a time conversion error, data uploaded from the iPro™2 recorder to the CareLink iPro software using the new CareLink iPro Uploader feature may result in incorrect reports.
Remedy Action:Reports generated using the uploader feature may contain inaccurate data, and should not be used to make therapy adjustments. Medtronic advises repeating iPro2 evaluations for those studies uploaded between September 23, 2017 and September 27, 2017.
Clinics do not need to uninstall the uploader feature. As stated above, the Uploader has been disabled, and the Java™ Applet will upload your recorder and meter data.
Athorized Representative/Importer/Distributor:Medtronic Saudi Arabia
Report Source:NCMDR
Source Ref. Number:505361207B19F
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Medtronic.pdf