DIGOXIN REAGENT Adverse Event — Malfunction (MDR MW5005586)
DIGOXIN REAGENT Adverse Event — Malfunction (MDR MW5005586) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: DIGOXIN REAGENT; Generic name: NONE; Manufacturer: BECKMAN COULTER, INC.
| Device | DIGOXIN REAGENT |
|---|---|
| Generic name | NONE |
| Manufacturer | BECKMAN COULTER, INC |
| Report number | MW5005586 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-18 |
| Narrative | THE UCH CLINICAL LABORATORY EXPERIENCED LOW RECOVERY OF DIGOXIN IN ITS ASSAY AS IDENTIFIED BY CARE PROVIDERS. DATE RANGE OF LOW RECOVERY APPEARS TO BE IN 2007 THROUGH 2008. PROBLEM FIRST BROUGHT TO LAB'S ATTENTION APPROX JAN 31, 2008. INVESTIGATION SHOWED DETERIORATION OF CALIBRATION 5-7 DAYS AFTER CALIBRATION -MFG STATES WITHIN- LOT CALIBRATION STABILITY OF 42 DAYS-. VENDOR WAS CONTACTED 2-1-08 B |
| Source | openFDA MAUDE (device adverse events) |
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