ANALYTICAL E MODULE Adverse Event — Malfunction (MDR 1823260-2008-01605)
ANALYTICAL E MODULE Adverse Event — Malfunction (MDR 1823260-2008-01605) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ANALYTICAL E MODULE; Generic name: IMMUNOCHEMISTRY ANALYZER -JJE; Manufacturer: ROCHE DIAGNOSTICS.
| Device | ANALYTICAL E MODULE |
|---|---|
| Generic name | IMMUNOCHEMISTRY ANALYZER -JJE |
| Manufacturer | ROCHE DIAGNOSTICS |
| Report number | 1823260-2008-01605 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-15 |
| Report source | Health Professional, User facility |
| Narrative | ONE PT SAMPLE WITH DISCREPANT TOTAL PSA RESULTS. INITIAL RESULT GAVE 12.03 NG/ML; SAMPLE REPEATED IN 2008 GAVE 52.39 NG/ML. A SECOND SAMPLE FROM THE SAME PT GAVE 52.34 NG/ML. FALSELY LOW RESULTS WERE NOT REPRODUCIBLE UPON RERUN. THE INVESTIGATIONAL UNIT WAS UNABLE TO IDENTIFY A SPECIFIC ROOT CAUSE. |
| Source | openFDA MAUDE (device adverse events) |
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