MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-01-17 for ANTI-HUMAN GLOBULIN (RABBIT/MURINE MONOCLONAL) 804115100 manufactured by Bio-rad Medical Diagnostics Gmbh.
[1842975]
The customer reported that cap proficiency test for the dat b s on sample #6 failed to react positively with anti-human globulin anti-igg, -c3d, polyspecific art no. 804115100, lot 7913070-02. The customer has sent us neither the survey sample nor the complained reagent. Therefore, the retention sample was tested with the survey sample dat-06 of the quality control laboratory which has the same specificity as the control used by customer. The survey sample of qc reacted correctly positive with the affected lot of anti-human globulin anti-igg, c3d, polyspecific.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610824-2011-00007 |
| MDR Report Key | 1983144 |
| Report Source | 05 |
| Date Received | 2011-01-17 |
| Date of Report | 2011-01-19 |
| Date of Event | 2010-10-10 |
| Date Mfgr Received | 2010-12-27 |
| Date Added to Maude | 2012-01-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DR MARC GORZELLIK, HEAD |
| Manufacturer Street | INDUSTRIESTRASSE 1 |
| Manufacturer City | DREIEICH 63303 |
| Manufacturer Country | GM |
| Manufacturer Postal | 63303 |
| Manufacturer Phone | 103801528 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANTI-HUMAN GLOBULIN (RABBIT/MURINE MONOCLONAL) |
| Generic Name | ANTI-HUMAN GLOBULIN, ANTI-IGG, -C3D, POLY. |
| Product Code | GMS |
| Date Received | 2011-01-17 |
| Catalog Number | 804115100 |
| Lot Number | 7913070-02 |
| Device Expiration Date | 2011-06-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIO-RAD MEDICAL DIAGNOSTICS GMBH |
| Manufacturer Address | INDUSTRIESTRASSE 1 DREIEICH D-63303 GM D-63303 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-01-17 |