ELECSYS 2010 RACK Adverse Event — Malfunction (MDR 1823260-2008-01604)
ELECSYS 2010 RACK Adverse Event — Malfunction (MDR 1823260-2008-01604) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ELECSYS 2010 RACK; Generic name: IMMUNODIAGNOSTIC ANALYZER - JJE; Manufacturer: ROCHE DIAGNOSTICS.
| Device | ELECSYS 2010 RACK |
|---|---|
| Generic name | IMMUNODIAGNOSTIC ANALYZER - JJE |
| Manufacturer | ROCHE DIAGNOSTICS |
| Report number | 1823260-2008-01604 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-15 |
| Report source | Health Professional, User facility |
| Narrative | MULTIPLE PTS WITH DISCREPANT RESULTS FOR MULTIPLE TESTS. THE FOLLOWING EXAMPLES WERE PROVIDED. SAMPLE #, TEST NAME, ORIGINAL RESULT/REPEAT RESULT/UNITS. CKMB 1.93/2.46 NG/ML. TNT 0.138/0.203 NG/ML. CKMB 1.08/3.36 NG/ML. CKMB <0.10/1.96 NG/ML. MYO <21/25.78 NG/ML. CKMB 3.69/14.8 NG/ML. CKMB 0.592/3.59 NG/ML. CKMB <0.100/1.98 NG/ML. CKMB 0.387/2.83 NG/ML. TNT 0.032/0.177 NG/ML. CKMB 0.64/2.75 NG/ML. |
| Source | openFDA MAUDE (device adverse events) |
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