MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-08-23 for ANTI-HUMAN GLOBULIN ANTI-IGG 804175100 manufactured by Bio-rad Medical Diagnostics Gmbh.
[2158370]
The customer complained that they missed two antibodies (anti-e and anti-cw) with anti-igg art#: (b)(4), lot# 7039091-04. Customer has sent us neither the pt sample nor the allegedly defective sample anti-igg. Therefore, the retention sample of anti-igg was tested in our quality control lab, using different weak antibodies. All positive and negative reactions were correct. We did not observe any false negative reactions. Testing of our quality control lab confirmed the correct function of the complained lot of anti-igg. A review of the batch record documentation showed no irregularities which might have affected negatively the quality of the complained lot.
Patient Sequence No: 1, Text Type: D, B5
[9474954]
Add'l event date: (b)(6) 2011.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610824-2011-00115 |
| MDR Report Key | 2254838 |
| Report Source | 05 |
| Date Received | 2011-08-23 |
| Date of Report | 2011-08-23 |
| Date of Event | 2011-06-22 |
| Date Mfgr Received | 2011-07-25 |
| Date Added to Maude | 2012-05-18 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 ANTI-IGG |
| Generic Name | AHG ANTI-IGG |
| Product Code | LKJ |
| Date Received | 2011-08-23 |
| Catalog Number | 804175100 |
| Lot Number | 7039091-04 |
| Device Expiration Date | 2013-09-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2011-08-23 |