MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-11-16 for DADE DIMENSION AR DIMENSION AR, DIRECT BILIRUBIN * manufactured by Dade Behring,inc..
[18447900]
Dade dimension ar instrument has a direct bilirubin method. The method has had bad lots of reagents that do not work on the instrument. Laboratory had notified dade of instrument error codes. Dade would have lab troubleshoot problems related to the instrument. After this problem continued, they realized it was a bad lot of reagent. New reagent was shipped to replace the bad lot of direct bilirubin. The new lot of reagent was also bad for direct bilirubin. Of the 5 lots listed in the memo, 11/5/99, to dade field svc reps, hospital had received three lots that were bad (jm0278, wv0261, ga0204). No notification to the customer was ever made that these reagent lots had a problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1017577 |
| MDR Report Key | 250475 |
| Date Received | 1999-11-16 |
| Date of Report | 1999-11-16 |
| Date Added to Maude | 1999-11-22 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DADE DIMENSION AR |
| Generic Name | CHEMISTRY ANALYZER |
| Product Code | JFM |
| Date Received | 1999-11-16 |
| Model Number | DIMENSION AR, DIRECT BILIRUBIN |
| Catalog Number | * |
| Lot Number | JM0278, WB0261, GA0204 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 242657 |
| Manufacturer | DADE BEHRING,INC. |
| Manufacturer Address | RT. 896, GLASCOW BLDG. 500 NEWARK DE 19714 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-11-16 |