MODULAR ANALYTICS CORE Adverse Event — Malfunction (MDR 1823260-2008-01651)
MODULAR ANALYTICS CORE Adverse Event — Malfunction (MDR 1823260-2008-01651) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: MODULAR ANALYTICS CORE; Generic name: CLINICAL CHEMISTRY ANALYZER - JJE; Manufacturer: ROCHE DIAGNOSTICS.
| Device | MODULAR ANALYTICS CORE |
|---|---|
| Generic name | CLINICAL CHEMISTRY ANALYZER - JJE |
| Manufacturer | ROCHE DIAGNOSTICS |
| Report number | 1823260-2008-01651 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-18 |
| Report source | Health Professional, User facility |
| Narrative | USER EXPERIENCING DISCREPANT BICARBONATE RESULTS FOR A COUPLE OF WEEKS. APPROXIMATELY 22 SAMPLES TESTED IN 2008, WERE EFFECTED. REPEAT TESTING PERFORMED THE NEXT DAY. PATIENT 1, INITIAL GAVE 33 MMOL/L; REPEAT GAVE 26 MMOL/L. USER RECALIBRATED AND CHANGED CUVETTES. IF ADD'L INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED. |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →