MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-05-09 for ANTI-HUMAN GLOBULIN (RABBIT, POLYCLONAL) 806516100 manufactured by Bio-rad Medical Diagnostics Gmbh.
[2116041]
The customer complained a false negative reaction of a pt sample containing an anti-m with anti-human globulin anti-igg solidscreen ii. We received the sample but not the complained lot of anti-human globulin anti-igg solidscreen ii. Sample was tested with retention sample of anti-human globulin anti-igg solidscreen ii and screening cells on tango in the quality control laboratory and reacted negative. Furthermore, the sample was tested in the gel method and reacted also negative. Additionally, the sample was tested in the tube technique at different temperatures and incubation times. The sample reaction weakly positive. The sample was also tested with the identification cells biotestcell-i11 on tango. One m homozygous red cell reacted weakly positive. Eval of all tests confirm the weakness of the missed antibody.
Patient Sequence No: 1, Text Type: D, B5
[9155565]
The stn# 125098.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610824-2011-00057 |
| MDR Report Key | 2137847 |
| Report Source | 05 |
| Date Received | 2011-05-09 |
| Date of Report | 2011-05-09 |
| Date of Event | 2011-04-12 |
| Date Mfgr Received | 2011-04-12 |
| Date Added to Maude | 2012-04-02 |
| 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 (RABBIT, POLYCLONAL) |
| Generic Name | AHG ANTI-IGG SOLIDSCREEN II |
| Product Code | DEW |
| Date Received | 2011-05-09 |
| Catalog Number | 806516100 |
| Lot Number | 7035091-03 |
| Device Expiration Date | 2012-02-25 |
| 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 | 2011-05-09 |