FREESTYLE Adverse Event — Injury (MDR 2954323-2008-00826)
FREESTYLE Adverse Event — Injury (MDR 2954323-2008-00826) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: FREESTYLE; Generic name: BLOOD GLUCOSE MONITORING SYSTEM; Manufacturer: ABBOTT DIABETES CARE INC, USA.
| Device | FREESTYLE |
|---|---|
| Generic name | BLOOD GLUCOSE MONITORING SYSTEM |
| Manufacturer | ABBOTT DIABETES CARE INC, USA |
| Report number | 2954323-2008-00826 |
| Event type | Injury |
| Product problem | N |
| Date received | 2008-02-15 |
| Report source | Consumer |
| Narrative | A CUSTOMER REPORTED THAT THEIR FREESTYLE BLOOD GLUCOSE MONITOR WOULD NOT ACTIVATE AFTER A BLOOD SAMPLE WAS APPLIED TO THE TEST STRIP. HE THEN REPORTED EXPERIENCING HALLUCINATIONS. HE WAS TAKEN TO A MEDICAL FACILITY WHERE HE WAS DIAGNOSED WITH SEVERE HYPERGLYCEMIA. HE WAS MONITORED FOR 2 HOURS AND THEN DISCHARGED. TREATMENT ADMINISTERED TO STABILIZE GLUCOSE LEVELS IS UNKNOWN. THERE WAS NO REPORT OF |
| Source | openFDA MAUDE (device adverse events) |
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