ELECSYS 2010 RACK Adverse Event — Malfunction (MDR 1823260-2008-01597)
ELECSYS 2010 RACK Adverse Event — Malfunction (MDR 1823260-2008-01597) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ELECSYS 2010 RACK; Generic name: IMMUNOCHEMISTRY ANALYZER -JJE; Manufacturer: ROCHE DIAGNOSTICS.
| Device | ELECSYS 2010 RACK |
|---|---|
| Generic name | IMMUNOCHEMISTRY ANALYZER -JJE |
| Manufacturer | ROCHE DIAGNOSTICS |
| Report number | 1823260-2008-01597 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-15 |
| Report source | Health Professional, User facility |
| Narrative | ONE PT WITH DISCREPANT TROPONIN T RESULTS. INITIAL RESULT GAVE 0.122 UG/L; REPEATED TWICE GIVING 0.016 AND 0.019 UG/L. IF ADD'L INFO IS REC'D, APPROPRIATE NOTIFICATION WILL BE PROVIDED. |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →