ELECSYS 2010 RACK Adverse Event — Malfunction (MDR 1823260-2008-01598)
ELECSYS 2010 RACK Adverse Event — Malfunction (MDR 1823260-2008-01598) 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 CORP..
| Device | ELECSYS 2010 RACK |
|---|---|
| Generic name | IMMUNOCHEMISTRY ANALYZER - JJE |
| Manufacturer | ROCHE DIAGNOSTICS CORP. |
| Report number | 1823260-2008-01598 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-15 |
| Report source | Health Professional, User facility |
| Narrative | ONE PT SAMPLE WITH DISCREPANT ESTRADIOL RESULTS. INITIAL RESULT GAVE 5.28 PG/ML; REPEAT GAVE 1937 PG/ML. THE INVESTIGATIONAL UNIT WAS UNABLE TO DETERMINE THE SPECIFIC ROOT CAUSE OF THE COMPLAINT. |
| Source | openFDA MAUDE (device adverse events) |
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