TRUE METRIX Adverse Event — Malfunction (MDR 1000113657-2020-00263)
TRUE METRIX Adverse Event — Malfunction (MDR 1000113657-2020-00263) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: TRUE METRIX; Generic name: SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER; Manufacturer: TRIVIDIA HEALTH INC.
| Device | TRUE METRIX |
|---|---|
| Generic name | SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER |
| Manufacturer | TRIVIDIA HEALTH INC |
| Report number | 1000113657-2020-00263 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | CONSUMER |
| Narrative | SECTIONS WITH ADDITIONAL INFORMATION AS OF (B)(6) 2020: H6: UPDATED FDA'S METHOD, RESULT, AND CONCLUSION CODES H10: METER WAS NOT RETURNED FOR EVALUATION. TEST STRIPS WERE NOT RETURNED FOR EVALUATION. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIP LOT TESTED AND PASSED. |
| Source | openFDA MAUDE (device adverse events) |
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