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.
[2158369]
The customer complained that they missed an incompatible crossmatch caused by anti-igg art#: (b)(4), lot 7039091-04. Customer reported they detected anti-jk(a) and anti-fy(a) but missed an anti-e and got therefore an transfusion reaction. Customer sent us the pt sample, the complaint sample anti-igg and the anti-igg of a competitor. The pt sample was tested with the allegedly defective anti-igg in parallel to the competitor's anti-igg. Both reagents showed completely identical reactions. Further tests showed that the add'l antibody was not an anti-e but anti-k. This antibody could be identified unambiguously with the complaint sample anti-igg, testing of quality control lab confirmed the correct function of the complained anti-igg lot. A review of the batch record documentation showed no irregularities which might have affected negatively the complained lot's quality.
Patient Sequence No: 1, Text Type: D, B5
[9393189]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610824-2011-00107 |
| MDR Report Key | 2254835 |
| Report Source | 05 |
| Date Received | 2011-08-23 |
| Date of Report | 2011-08-10 |
| Date of Event | 2011-06-30 |
| Date Mfgr Received | 2011-07-12 |
| 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 | Y |
| Device Eval'ed by Mfgr | Y |
| 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 |