TRUE METRIX AIR Adverse Event — Malfunction (MDR 1000113657-2020-00260)
TRUE METRIX AIR Adverse Event — Malfunction (MDR 1000113657-2020-00260) 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 | 1000113657-2020-00260 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | FOREIGN |
| Narrative | INTERNAL REPORT REFERENCE NUMBER: (B)(4). PRODUCT NOT AVAILABLE FOR EVALUATION. SUBCONTRACTOR ROOT CAUSE: INSUFFICIENT/IMPROPER PROCESS CONTROLS WERE IN PLACE TO PREVENT PRODUCT COMMINGLING TEMP. RECALL REPORT NO. 100113657-04/16/2020-001-R THE ISSUE WAS IDENTIFIED AS A RESULT OF A COMPLAINT RECEIVED FROM (B)(6) AND REPORTED TO THE COMPANY (LEGAL MANUFACTURER OF THE FINISHED DEVICE - (B)(6), INC.) |
| Source | openFDA MAUDE (device adverse events) |
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