MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-04-12 for ANTI-HUMAN GLOBULIN ANTI-IGG SOLIDSCREEN 806516100 manufactured by Bio-rad Medical Diagnostics Gmbh.
[1945731]
The customer complained a false negative reaction of a known antibody positive sample on solidscreen on tango. We are still waiting for the sample and the complained product. The retention sample of the anti-human globulin, anti-igg solidscreen ii was tested with different weak antibodies. All positive and negative reactions were correct.
Patient Sequence No: 1, Text Type: D, B5
[9105701]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610824-2011-00044 |
| MDR Report Key | 2070586 |
| Report Source | 05,06 |
| Date Received | 2011-04-12 |
| Date of Report | 2011-04-12 |
| Date of Event | 2011-03-14 |
| Date Mfgr Received | 2011-03-16 |
| Date Added to Maude | 2011-05-11 |
| 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 | 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 | 2011-04-12 |
| Catalog Number | 806516100 |
| Lot Number | 7035090-02 |
| Device Expiration Date | 2011-10-12 |
| 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 | 2011-04-12 |