MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-06-15 for REAGENT RED BLOOD CELLS BIOTESTCELL 3 816085100 manufactured by Bio-rad Medical Diagnostics Gmbh.
[16728012]
The customer complained false positive reactions of three patient samples with cell 2 of biotestcell 3 in the gel card. We received one of the three affected samples and the complained lot of biotestcell 3. The sample was tested with complaint and retention sample of biotestcell 3 in gel card in our quality control laboratory. The sample reacted positive with cell 2 of both biotestcell 3. Furthermore, the sample was tested in the gel method at 4 degrees celsius. All three cells of biotestcell 3 and the autocontrol reacted positive. Additionally, the sample was tested in the tube technique (liss 10 min at 37 degrees celsius and indirect anti-human globulin test). It reacted negative in the tube methods. The correct function of the affected lot biotestcell 3 was confirmed by testing different positive and negative samples. All positive and negative reactions were correct. Only the customer sample reacted positive with cell 2 of biotestcell 3 in the gel card. The intended use of the product is the detection of unexpected antibodies in the tube test and solid phase test solidscreen ii with tango optimo.
Patient Sequence No: 1, Text Type: D, B5
[16934160]
Stn # 125207-08.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610824-2011-00080 |
| MDR Report Key | 2149044 |
| Report Source | 05 |
| Date Received | 2011-06-15 |
| Date of Report | 2011-06-15 |
| Date of Event | 2011-05-17 |
| Date Mfgr Received | 2011-05-17 |
| Date Added to Maude | 2011-08-30 |
| 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 | REAGENT RED BLOOD CELLS BIOTESTCELL 3 |
| Generic Name | BIOTESTCELL 3 |
| Product Code | LKJ |
| Date Received | 2011-06-15 |
| Returned To Mfg | 2011-05-23 |
| Catalog Number | 816085100 |
| Lot Number | 8115011 |
| Device Expiration Date | 2011-05-31 |
| 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 | 2011-06-15 |