MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-08-30 for REAGENT RED BLOOD CELLS BIOTESTCELL 3 816085100 manufactured by Bio-rad Medical Diagnostics Gmbh.
[2194829]
The customer complained that two pt samples yielded false negative reactions with cell 1 of biotestcell 3. Both pts are supposed to have an anti-d. We received the two affected samples and the allegedly defective lot of biotestcell 3. Samples were tested with the complaint sample and the retention sample of biotestcell 3 in our quality control laboratory using different methods. Testing of the allegedly defective and the retention sample of biotestcell 3 yielded comparable results. The pt samples reacted weakly positive with cell 2 of biotestcell 3 and negatively with cell 1 of biotestcell 3. The samples were also tested using the gel method with the reagent red blood cells of a competitor. Cell 2 of this screening cells reacted positively while cell 1 resulted only in a +/- reaction. All testings confirm the weakness of the two antibodies. Moreover the antigenity of the affected d antigen of different reagent red blood cells may vary lightly. Testing of our quality control laboratory confirmed the correct function of the allegedly defective lot of biotestcell 3.
Patient Sequence No: 1, Text Type: D, B5
[9348912]
A review of the batch record documentation showed no irregularities which might have affected negatively the quality of the complained lot. Tango optimo specific data were requested for review but up to date despite several inquiries not received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610824-2011-00117 |
| MDR Report Key | 2261743 |
| Report Source | 05 |
| Date Received | 2011-08-30 |
| Date of Report | 2011-08-30 |
| Date of Event | 2011-08-03 |
| Date Mfgr Received | 2011-08-03 |
| Date Added to Maude | 2012-05-18 |
| 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 | 2011-08-30 |
| Returned To Mfg | 2011-08-17 |
| Catalog Number | 816085100 |
| Lot Number | 8127011 |
| Device Expiration Date | 2011-08-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2011-08-30 |