MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-08-03 for ANTI-HUMAN GLOBULIN ANTI-IGG SOLIDSCREEN II 806516100 manufactured by Bio-rad Medical Diagnostics Gmbh.
[2202398]
The customer had reported false negative reaction of a sample with anti-e. Customer has sent us neither the sample nor the complaint lot of anti-human globulin (ahg) anti-igg solidscreen ii. Therefore the retention sample of ahg anti-igg solidscreen ii was tested with positive and negative control and an anti-e from an interlaboratory comparison. All positive and negative reactions were correct. The anti-e reacted correctly positive with e positive screening cells. Summary: the testing quality control lab confirmed the correct function of the affected lot ahg anti-igg solidscreen ii. The 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
| Report Number | 9610824-2011-00101 |
| MDR Report Key | 2209626 |
| Report Source | 05 |
| Date Received | 2011-08-03 |
| Date of Report | 2011-08-04 |
| Date of Event | 2011-06-27 |
| Date Mfgr Received | 2011-07-11 |
| Date Added to Maude | 2012-06-20 |
| 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 |
| Manufacturer Street | INDUSTRIESTRAASE 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 SOLIDSCREEN II |
| Generic Name | AHG ANTI-IGG SOLIDSCREEN |
| Product Code | DEW |
| Date Received | 2011-08-03 |
| Catalog Number | 806516100 |
| Lot Number | 7035091-05 |
| Device Expiration Date | 2012-02-25 |
| 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 | 2011-08-03 |