TRUE METRIX AIR Adverse Event — Injury (MDR 1000113657-2020-00259)
TRUE METRIX AIR Adverse Event — Injury (MDR 1000113657-2020-00259) 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 | 1000113657-2020-00259 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-27 |
| Report source | CONSUMER |
| Narrative | INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER WAS RETURNED FOR EVALUATION. NO DEFECT WAS DETECTED. TEST STRIPS WERE RETURNED FOR EVALUATION. NO DEFECT WAS DETECTED. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-18: USER HAS HIGH GLUCOSE VALUE. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOM |
| Source | openFDA MAUDE (device adverse events) |
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