ELECSYS TOTAL PSA IMMUNOASSAY Adverse Event — Malfunction (MDR 1823260-2020-01113)
ELECSYS TOTAL PSA IMMUNOASSAY Adverse Event — Malfunction (MDR 1823260-2020-01113) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ELECSYS TOTAL PSA IMMUNOASSAY; Generic name: TOTAL,PROSTATE SPECIFIC ANTIGEN FOR DETECTION OF PROSTATE CA; Manufacturer: ROCHE DIAGNOSTICS.
| Device | ELECSYS TOTAL PSA IMMUNOASSAY |
|---|---|
| Generic name | TOTAL,PROSTATE SPECIFIC ANTIGEN FOR DETECTION OF PROSTATE CA |
| Manufacturer | ROCHE DIAGNOSTICS |
| Report number | 1823260-2020-01113 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | FOREIGN, HEALTH PROFESSIONAL, U |
| Narrative | THE CUSTOMER'S CALIBRATION AND QC WERE ACCEPTABLE. A GENERAL PRODUCT PROBLEM IS EXCLUDED. THE PATIENT'S SAMPLE WAS REQUESTED FOR INVESTIGATION, BUT THE PATIENT'S SAMPLE WAS NOT AVAILABLE. BASED ON THE AVAILABLE DATA, THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. |
| Source | openFDA MAUDE (device adverse events) |
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