ELECSYS TOXO IGG IMMUNOASSAY Adverse Event — Malfunction (MDR 1823260-2020-01122)
ELECSYS TOXO IGG IMMUNOASSAY Adverse Event — Malfunction (MDR 1823260-2020-01122) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ELECSYS TOXO IGG IMMUNOASSAY; Generic name: ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII; Manufacturer: ROCHE DIAGNOSTICS.
| Device | ELECSYS TOXO IGG IMMUNOASSAY |
|---|---|
| Generic name | ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII |
| Manufacturer | ROCHE DIAGNOSTICS |
| Report number | 1823260-2020-01122 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | HEALTH PROFESSIONAL |
| Narrative | SECTIONS D10 AND H3 WERE UPDATED. THE CUSTOMER'S CALIBRATION SIGNALS AND CONTROLS WERE PROVIDED AND FOUND TO BE WITHIN RANGE. THE SAMPLE WAS RETURNED FOR INVESTIGATION. THE CUSTOMER'S ELECSYS TOXO IGG RESULTS WERE REPRODUCIBLE. THE RESULTS FOR THE ELECSYS TOXO IGM ASSAY WERE NEGATIVE. THEREFORE THESE RESULTS ARE INDICATIVE OF A LATER-STAGE INFECTION. THE CUSTOMER'S REAGENT PERFORMED WITHIN SPECIFI |
| Source | openFDA MAUDE (device adverse events) |
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