ANALYTICAL E MODULE Adverse Event — Malfunction (MDR 1823260-2008-01599)
ANALYTICAL E MODULE Adverse Event — Malfunction (MDR 1823260-2008-01599) 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 | 1823260-2008-01599 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-15 |
| Report source | Health Professional, User facility |
| Narrative | USER REPORTS RECEIVING DISCREPANT RESULTS FOR ESTRADIOL FOR MANY SAMPLES. USER DID NOT PROVIDE AN EXACT NUMBER OF SAMPLES. ONLY THE FOLLOWING TWO EXAMPLES WERE PROVIDED: PT 1, INITIAL RESULT GAVE 3800 PG/ML; REPEAT GAVE 1920 PG/ML. PT 2, INITIAL RESULT GAVE 12000 PG/ML; REPEAT GAVE 10800 PG/ML. IF ADDITIONAL INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED. |
| Source | openFDA MAUDE (device adverse events) |
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