ACCESS 2 IMMUNOASSAY SYSTEM Adverse Event — Malfunction (MDR 2122870-2008-00052)
ACCESS 2 IMMUNOASSAY SYSTEM Adverse Event — Malfunction (MDR 2122870-2008-00052) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ACCESS 2 IMMUNOASSAY SYSTEM; Generic name: DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER; Manufacturer: BECKMAN COULTER, INC..
| Device | ACCESS 2 IMMUNOASSAY SYSTEM |
|---|---|
| Generic name | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER |
| Manufacturer | BECKMAN COULTER, INC. |
| Report number | 2122870-2008-00052 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-18 |
| Report source | Health Professional |
| Narrative | A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) AND STATED THAT THEY MAY HAVE A PRECISION ISSUE ON THE ACCESS 2 INSTRUMENT. A PT SAMPLE WAS TESTED FOR TROPONIN (ACCU TNI) AND A RESULT OF 0.33NG/ML WAS OBTAINED. THE SAMPLE WAS TESTED ON A DIFFERENT INSTRUMENT IN THE CUSTOMER'S LAB AND ACCU TNI RESULT WAS 13.30NG/ML. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LAB. THE CUSTOMER DID NOT RECEIV |
| Source | openFDA MAUDE (device adverse events) |
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