MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-04-04 for REAGENT RED BLOOD CELLS BIOTESTCELL 3 816085100 manufactured by Bio-rad Medical Diagnostics Gmbh.
[1950001]
The customer complained of false negative reactions of a proficiency sample (aut-02) containing anti-e. We received the proficiency sample (aut-02) but not the complaint lot of biotestcell 3. 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 information 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. The correct function of the affected lot biotestcell 3 was confirmed by testing different weak antibodies. All positive and negative reactions were correct. Testing at the quality control laboratory confirmed the correct function of the complaint lot of biotestcell 3. A review of the batch record documentation showed no irregularities which might have affected negatively the quality of the complained lot.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610824-2011-00038 |
| MDR Report Key | 2070570 |
| Report Source | 05 |
| Date Received | 2011-04-04 |
| Date of Report | 2011-04-04 |
| Date of Event | 2011-01-28 |
| Date Mfgr Received | 2011-03-07 |
| Date Added to Maude | 2011-06-03 |
| 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 | REAGENT RED BLOOD CELLS BIOTESTCELL 3 |
| Generic Name | BIOTESTCELL 3 |
| Product Code | LKJ |
| Date Received | 2011-04-04 |
| Catalog Number | 816085100 |
| Lot Number | 7051021 |
| Device Expiration Date | 2011-02-08 |
| 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 | 2011-04-04 |