VITROS CHEMISTRY PRODUCTS VALP REAGENT Adverse Event — Malfunction (MDR 1319808-2020-00021)
VITROS CHEMISTRY PRODUCTS VALP REAGENT Adverse Event — Malfunction (MDR 1319808-2020-00021) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: VITROS CHEMISTRY PRODUCTS VALP REAGENT; Generic name: IN-VITRO DIAGNOSTIC; Manufacturer: ORTHO-CLINICAL DIAGNOSTICS.
| Device | VITROS CHEMISTRY PRODUCTS VALP REAGENT |
|---|---|
| Generic name | IN-VITRO DIAGNOSTIC |
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS |
| Report number | 1319808-2020-00021 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | HEALTH PROFESSIONAL |
| Narrative | THE INVESTIGATION DETERMINED LOWER THAN EXPECTED VALPROIC ACID (VALP) RESULTS WERE OBTAINED FROM NON-VITROS (BIORAD) QUALITY CONTROL (QC) FLUIDS USING VITROS CHEMISTRY PRODUCTS VALP REAGENT LOT 2511-27-7325 ON A VITROS 5600 INTEGRATED SYSTEM. THE MOST LIKELY CAUSE OF THE EVENT IS AN ISSUE RELATED TO THE BIORAD QUALITY CONTROL FLUIDS INVOLVING EITHER PRE-ANALYTICAL SAMPLE MIX-UP OR IMPROPER PRE-ANA |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →