TRUE METRIX AIR Adverse Event — Malfunction (MDR 1000113657-2020-00265)
TRUE METRIX AIR Adverse Event — Malfunction (MDR 1000113657-2020-00265) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: TRUE METRIX AIR; Generic name: SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER; Manufacturer: TRIVIDIA HEALTH INC.
| Device | TRUE METRIX AIR |
|---|---|
| Generic name | SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER |
| Manufacturer | TRIVIDIA HEALTH INC |
| Report number | 1000113657-2020-00265 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | CONSUMER |
| Narrative | INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-58: USER HAD AN INACCURATE REFERENCE: SELF: THE PERSON IS USING THEMSELVES AS THE REFERENCE OR HOW THEY FEEL AT THE TIME THEY RUN THE BLOOD TEST. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CON |
| Source | openFDA MAUDE (device adverse events) |
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