INRATIO Adverse Event — Malfunction (MDR 2954730-2008-00075)
INRATIO Adverse Event — Malfunction (MDR 2954730-2008-00075) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: INRATIO; Generic name: PROTHROMBIN TIME TEST; Manufacturer: HEMOSENSE SJ.
| Device | INRATIO |
|---|---|
| Generic name | PROTHROMBIN TIME TEST |
| Manufacturer | HEMOSENSE SJ |
| Report number | 2954730-2008-00075 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-19 |
| Report source | Unknown |
| Narrative | DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: 2008; INRATIO: 1.6; LAB: 4.6; MEAN: 3.1; CONFIDENCE LIMITS: 1.9-4.6; INRATIO: 4.5; LAB: 6.3; MEAN: 5.4; CONFIDENCE LIMITS: CANNOT BE DETERMINED; INRATIO: 1.5; LAB: 4.45; MEAN: 2.975; CONFIDENCE LIMITS: 1.8-4.2; INRATIO: 5.1; LAB: 5.6; MEAN: 5.35; CONFIDENCE LIMITS: CANN |
| Source | openFDA MAUDE (device adverse events) |
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