MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-04-19 for ANTI-HUMAN GLOBULIN SOLIDSCREENII - DONOR 806516 manufactured by Bio-rad Medical Diagnostics Gmbh.
[17532575]
The customer complained false negative reactions of a control with anti-human globulin solidscreen ii-donor after using the same bottle for about three weeks.
Patient Sequence No: 1, Text Type: D, B5
[17654933]
Summary: the testing of the quality control laboratory confirmed the correct function of the complained lot of anti-human globulin solidscreen ii-donor. According to the instruction for use, a handling's failure of customer cannot be excluded. The review of the batch record documentation showed no irregularities which might have affected negatively the quality of the complained lot. We had further complaints related to this lot. Stn# 125098.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610824-2011-00050 |
| MDR Report Key | 2101874 |
| Report Source | 05 |
| Date Received | 2011-04-19 |
| Date of Report | 2011-04-18 |
| Date of Event | 2011-03-25 |
| Date Mfgr Received | 2011-03-25 |
| Date Added to Maude | 2012-02-17 |
| 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 SOLIDSCREENII - DONOR |
| Generic Name | ANTI-HUMAN GLOBULIN SOLIDSCREENII - DONOR |
| Product Code | DEW |
| Date Received | 2011-04-19 |
| Catalog Number | 806516 |
| Lot Number | 1023070 |
| Device Expiration Date | 2011-12-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2011-04-19 |