UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS Adverse Event — Malfunction (MDR 2050012-2008-00008)
UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS Adverse Event — Malfunction (MDR 2050012-2008-00008) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS; Generic name: CLINICAL CHEMISTRY ANALYZER; Manufacturer: BECKMAN COULTER, INC..
| Device | UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS |
|---|---|
| Generic name | CLINICAL CHEMISTRY ANALYZER |
| Manufacturer | BECKMAN COULTER, INC. |
| Report number | 2050012-2008-00008 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-13 |
| Report source | Health Professional |
| Narrative | A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING FALSE LOW POTASSIUM (K) RESULTS THAT WERE GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYS. PT A AND B SAMPLES WERE TESTED FOR K AND RESULTS WERE: 4.7MMOL/L FOR PT AND 4.0MMOL/L FOR PT B. THE ORIGINAL SAMPLES WERE RE-TESTED FOR K AND HIGHER RESULTS WERE OBTAINED : 5.7 MMOL/L FOR PT A AND 5.0MMOL/L FOR PT B. IT IS UNK IF TREATMENT W |
| Source | openFDA MAUDE (device adverse events) |
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