OT VERIO FLEX METER Adverse Event — Injury (MDR 3008382007-2020-03904)
OT VERIO FLEX METER Adverse Event — Injury (MDR 3008382007-2020-03904) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: OT VERIO FLEX METER; Generic name: GLUCOSE MONITORING SYS/KIT; Manufacturer: LIFESCAN EUROPE GMBH.
| Device | OT VERIO FLEX METER |
|---|---|
| Generic name | GLUCOSE MONITORING SYS/KIT |
| Manufacturer | LIFESCAN EUROPE GMBH |
| Report number | 3008382007-2020-03904 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-28 |
| Report source | CONSUMER, FOREIGN |
| Narrative | THE LAY USER/PATIENT¿S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. IN ADDITION, A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE SUBJECT METER LOT. THE REVIEW DID NOT IDENTIFY ANYTHING THAT COULD ADVERSELY IMPACT PRODUCT PERFORMANCE OR FUNCTION. I |
| Source | openFDA MAUDE (device adverse events) |
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