MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-12-15 for REAGENT RED BLOOD CELLS BIOTESTCELL 3 816085100 manufactured by Bio-rad Medical Diagnostics Gmbh.
[2779096]
The customer complained that an anti-e didn't react positive with biotestcell p3 art (b)(4), lot 7039021 on tango. The customer has sent us the affected sample. The complaint product biotestcell p3 was not sent. Therefore the quality control laboratory tested the retention sample of the complained lot biotestcell p3 in combination with the sample on tango. We could confirm a negative reaction of the sample with cell 2 of biotestcell p3. The used positive and negative control reacted correctly and clearly positive respectively negative. Further testing in the diamed gel system showed negative reactions in the liss/ coombs technique. The three phase testing in the tube technique showed negative reactions at room temperature and at 37 degrees celsius. In the indirect anti-human globulin test only a +/- reaction was observed. The enzyme test with bromelain showed a 1+ positive reaction with the e positive cell. On tango the e positive enzyme treated red cell reacted strongly positive. The tests carried out show that this antibody (anti-e) is a very weak reacting antibody and preferentially reacting in the enzyme technique.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610824-2010-00017 |
| MDR Report Key | 2680362 |
| Report Source | 05 |
| Date Received | 2010-12-15 |
| Date of Report | 2010-12-09 |
| Date of Event | 2010-11-09 |
| Date Mfgr Received | 2010-11-12 |
| Date Added to Maude | 2012-08-07 |
| 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 | 2010-12-15 |
| Catalog Number | 816085100 |
| Lot Number | 7039021 |
| Device Expiration Date | 2010-11-16 |
| 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 | 2010-12-15 |