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 Med Diagnostics Gmbh.
[1964078]
The customer reported that cap survey (b)(4) failed to react (b)(6) with anti-human globulin anti-igg, -c3d, polyspecific (b)(4), lot 7836090-02. The customer has sent us the survey sample and the complained reagent. Both were tested in quality control laboratory. The survey sample reacted correctly (b)(6) with the affected lot of anti-human globulin anti-igg, -c3d, polyspecific.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610824-2011-00005 |
| MDR Report Key | 1983143 |
| Report Source | 05 |
| Date Received | 2011-01-17 |
| Date of Report | 2011-01-18 |
| Date of Event | 2010-10-15 |
| Date Mfgr Received | 2010-12-20 |
| Date Added to Maude | 2012-01-26 |
| 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 OF QM/RA |
| 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 |
| Returned To Mfg | 2011-01-03 |
| Catalog Number | 804115100 |
| Lot Number | 7836090-02 |
| Device Expiration Date | 2010-11-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIO-RAD MED DIAGNOSTICS GMBH |
| Manufacturer Address | INDUSTRIESTRASSE 1 DREIEICH D-63303 GM D-63303 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-01-17 |