UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM Adverse Event — Malfunction (MDR 2122870-2008-00053)
UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM Adverse Event — Malfunction (MDR 2122870-2008-00053) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM; Generic name: DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER; Manufacturer: BECKMAN COUL
| Device | UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM |
|---|---|
| Generic name | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER |
| Manufacturer | BECKMAN COULTER, INC. |
| Report number | 2122870-2008-00053 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-18 |
| Report source | Health Professional |
| Narrative | A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUSLY HIGH FREE T4 (FT4) AND LOW HUMAN THYROID-STIMULATING HORMONE (HTSH) RESULTS THAT WERE GENERATED BY THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. A PATIENT SAMPLE WAS TESTED FOR FREE T4 AND HTSH AND RESULTS WERE: FT4- 1.48NG/ML; HTSH- 1.75UIU/ML. THE SAMPLE WAS ALIQUOTED AND TESTED ON A DIFFERENT INSTRUMENT IN THE CUSTOMER |
| Source | openFDA MAUDE (device adverse events) |
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