DIMENSION CLINICAL CHEMISTRY SYSTEM Adverse Event — Malfunction (MDR 1226181-2008-00013)
DIMENSION CLINICAL CHEMISTRY SYSTEM Adverse Event — Malfunction (MDR 1226181-2008-00013) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: DIMENSION CLINICAL CHEMISTRY SYSTEM; Generic name: CLINICAL CHEMISTRY SYSTEM; Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS INC..
| Device | DIMENSION CLINICAL CHEMISTRY SYSTEM |
|---|---|
| Generic name | CLINICAL CHEMISTRY SYSTEM |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Report number | 1226181-2008-00013 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-19 |
| Report source | Health Professional |
| Narrative | A FALSELY ELEVATED TROPONIN I RESULT OF 19.33 NG/ML WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE SAMPLE WAS RETESTED AND A RESULT OF <0.04 NG/ML WAS OBTAINED. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED TROPONIN I RESULT. ANALYSIS OF THE INSTRUMEN |
| Source | openFDA MAUDE (device adverse events) |
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