ELECSYS 2010 DISK Adverse Event — Malfunction (MDR 1823260-2008-01600)
ELECSYS 2010 DISK Adverse Event — Malfunction (MDR 1823260-2008-01600) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ELECSYS 2010 DISK; Generic name: IMMUNOCHEMISTRY ANALYZER - JJE; Manufacturer: ROCHE DIAGNOSTICS.
| Device | ELECSYS 2010 DISK |
|---|---|
| Generic name | IMMUNOCHEMISTRY ANALYZER - JJE |
| Manufacturer | ROCHE DIAGNOSTICS |
| Report number | 1823260-2008-01600 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-15 |
| Report source | User facility |
| Narrative | USER PERFORMED COMPARISON STUDIES IN RESPONSE TO CONTROL RECOVERY ISSUES FOR TROPONIN T AND CKMB. THE FOLLOWING RESULTS WERE GENERATED DURING THE COMPARISON. REPEAT TESTING PERFORMED ON OTHER ANALYZE- SAME METHODOLOGY. SAMPLE 1: INITIAL TROPONIN T GAVE 0.044 NG/ML; REPEAT GAVE 0.033 NG/ML. SAMPLE 2: INITIAL TROPONIN T GAVE 0.034 NG/ML; REPEAT GAVE 0.023 NG/ML. SAMPLE REPEATED ON INITIAL ANALYZER G |
| Source | openFDA MAUDE (device adverse events) |
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