ASSURE PRO TEST STRIP Adverse Event — Malfunction (MDR 1832816-2008-00007)
ASSURE PRO TEST STRIP Adverse Event — Malfunction (MDR 1832816-2008-00007) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ASSURE PRO TEST STRIP; Generic name: BLOOD GLUCOSE TEST STRIPS; Manufacturer: PARLEX (EUROPE), LTD.
| Device | ASSURE PRO TEST STRIP |
|---|---|
| Generic name | BLOOD GLUCOSE TEST STRIPS |
| Manufacturer | PARLEX (EUROPE), LTD |
| Report number | 1832816-2008-00007 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-13 |
| Report source | Health Professional |
| Narrative | CALLER INDICATED THE ASSURE PRO METER WAS GIVING VARIABLE READINGS. 70, TEN MINUTES LATER 325, THIRD READING 120. SHE HAS NO FURTHER DETAILS ON THE INCIDENT. IT HAPPENED TOO LONG AGO. |
| Source | openFDA MAUDE (device adverse events) |
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