ANALYTICAL P MODULE Adverse Event — Malfunction (MDR 1823260-2008-01603)
ANALYTICAL P MODULE Adverse Event — Malfunction (MDR 1823260-2008-01603) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ANALYTICAL P MODULE; Generic name: CLINICAL CHEMISTRY ANALYZER- JJE; Manufacturer: ROCHE DIAGNOSTICS.
| Device | ANALYTICAL P MODULE |
|---|---|
| Generic name | CLINICAL CHEMISTRY ANALYZER- JJE |
| Manufacturer | ROCHE DIAGNOSTICS |
| Report number | 1823260-2008-01603 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-15 |
| Report source | Health Professional, User facility |
| Narrative | ACCOUNT EXPERIENCING DISCREPANT RESULTS FOR ALBUMIN FOR MULTIPLE PT SAMPLES. THE FOLLOWING EXAMPLES WERE PROVIDED. SAMPLE 1: INITIAL GAVE 36.3 G/L. SAMPLE WAS DILUTED INITIALLY GIVING 570 G/L AND REPEAT GAVE 556 G/L. ANOTHER ALBUMIN VALUE WAS PROVIDED FOR THIS SAMPLE OF APPROX 10000 G/L - NO DOCUMENTATION PROVIDED TO DETERMINE IF THIS WAS AN ACTUAL VALUE OR A CALCULATED VALUE. SAMPLE 2: IN 2008, I |
| Source | openFDA MAUDE (device adverse events) |
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