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FREESTYLE FLASH Adverse Event — Injury (MDR 2954323-2008-00814)

FREESTYLE FLASH Adverse Event — Injury (MDR 2954323-2008-00814) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: FREESTYLE FLASH; Generic name: BLOOD GLUCOSE MONITORING SYSTEM; Manufacturer: ABBOTT DIABETES CARE INC, USA.

DeviceFREESTYLE FLASH
Generic nameBLOOD GLUCOSE MONITORING SYSTEM
ManufacturerABBOTT DIABETES CARE INC, USA
Report number2954323-2008-00814
Event typeInjury
Product problemN
Date received2008-02-15
Report sourceConsumer
NarrativeA CUSTOMER CALLED FOR HELP IN SETTING UP HIS FREESTYLE FLASH BLOOD GLUCOSE MONITOR. HE REPORTED THAT HE WAS UNABLE TO TEST BECAUSE HE COULD NOT PROPERLY CALIBRATE HIS METER. HE REPORTED THAT AS A RESULT OF NOT BEING ABLE TO PROPERLY TEST, HE EXPERIENCED HEADACHES AND PAIN THROUGHOUT HIS BODY. THE CUSTOMER WENT TO A LOCAL HOSPITAL WHERE HIS SUGAR REGISTERED AT 500 MG/DL. HE REPORTED BEING GIVEN AN
SourceopenFDA MAUDE (device adverse events)

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