MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-03-17 for ANTI-HUMAN GLOBULIN (RABBIT, POLYCLONAL) 806516100 manufactured by Bio-rad Medical Diagnostics Gmbh.
[1865511]
The customer complained a false negative reaction of sample a containing an anti-e and of sample b containing an anti-jk (a) with anti-human globulin, anti-igg solidscreen ii. Customer has sent us the two missed antibodies but not the complained lot of anti-human globulin, anti-igg solidscreen ii. The antibodies were tested with the retention samples of ahg on tango in the quality control laboratory and reacted negatively. Furthermore the antibodies were tested in the gel method: sample a reacted positively and sample b negatively. Additional tests in enzyme and peg (polyethylene-glycol) methods were performed. Sample a (anti-e) reacted positively in the enzyme technique on tango. Sample b (anti-jk (a)) reacted weakly positive only in the peg method and a jk (a) homozygous reagent red blood cell. The correct function of the affected lot ahg, anti-igg solidscreen ii was confirmed by testing different weak antibodies. All positive and negative reactions were correct.
Patient Sequence No: 1, Text Type: D, B5
[9172740]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610824-2011-00029 |
| MDR Report Key | 2049646 |
| Report Source | 05 |
| Date Received | 2011-03-17 |
| Date of Report | 2011-03-17 |
| Date of Event | 2011-02-10 |
| Date Mfgr Received | 2011-02-16 |
| Date Added to Maude | 2012-02-15 |
| 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 OF QM/RA |
| 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 | ANTI-HUMAN GLOBULIN ANTI-IGG SOLIDSCREEN |
| Product Code | LKJ |
| Date Received | 2011-03-17 |
| Catalog Number | 806516100 |
| Lot Number | 7016110-05 |
| Device Expiration Date | 2011-12-10 |
| 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 | 2011-03-17 |