MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-04-15 for ANTI-HUMAN GLOBULIN ANTI-IGG SOLIDSCREEN 806516100 manufactured by Bio-rad Medical Diagnostics Gmbh.
[2269592]
The customer complained false negative reactions of a proficiency sample (aut-02) containing anti-e. We received the proficiency sample (aut-02) but not the complained lot of anti-human globulin, anti-igg solidscreen ii. The proficiency sample was tested with the retention sample on tango in the quality control laboratory and reacted negatively. Furthermore a twofold serial dilution was tested on solidscreen ii and reacted correctly positive. Referred to informations of customer the proficiency sample aut-02 contains a monoclonal anti-e and not a natural occurring antibody. The intended use of solidscreen is amongst others the detection of irregular red cell antibodies in human blood.
Patient Sequence No: 1, Text Type: D, B5
[9399045]
Summary: the testing of the quality control laboratory confirmed the correct function of the complained lot of anti-human globulin, anti-igg solidscreen ii. The review of the batch record documentation showed no irregularities which might have affected negatively the quality of the complaint lot. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610824-2011-00048 |
| MDR Report Key | 2223970 |
| Report Source | 05,06 |
| Date Received | 2011-04-15 |
| Date of Report | 2011-04-15 |
| Date of Event | 2011-01-27 |
| Date Mfgr Received | 2011-03-23 |
| Date Added to Maude | 2011-12-21 |
| 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 ANTI-IGG SOLIDSCREEN |
| Generic Name | ANTI-HUMAN GLOBULIN ANTI-IGG SOLIDSCREEN |
| Product Code | DEW |
| Date Received | 2011-04-15 |
| Catalog Number | 806516100 |
| Lot Number | 7949130-04 |
| Device Expiration Date | 2011-05-25 |
| 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 | 2011-04-15 |