MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-06-17 for REAGENT RED BLOOD CELLS BIOTESTCELL 3 816085100 manufactured by Bio-rad Medical Diagnostics Gmbh.
[19653206]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[19843760]
The customer complained false (b)(6) reactions of pt samples with cell 2 of biotestcell 3 in the gel card. We received three affected samples but not the complained lot of biotestcell 3. The samples plus the retention sample of biotestcell 3 were tested with a gel card in our qc lab. The three samples showed (b)(6) reactions with cell 2 of biotestcell 3. Furthermore the samples were tested in the 3-phase-tube test and reacted (b)(6). The three samples showed only (b)(6) reactions in a tube method with prolonged incubation time at 4 degrees celsius. But this method is not conform to the described methods of instruction for use. The correct function of the affected lot biotestcell 3 was confirmed by testing different (b)(6) samples. All (b)(6) reactions were correct. The customer samples reacted (b)(6) 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 and not the gel system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610824-2011-00082 |
| MDR Report Key | 2149050 |
| Report Source | 05 |
| Date Received | 2011-06-17 |
| Date of Report | 2011-06-17 |
| Date of Event | 2011-05-23 |
| Date Mfgr Received | 2011-05-23 |
| Date Added to Maude | 2012-04-24 |
| 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 | 2011-06-17 |
| Catalog Number | 816085100 |
| Lot Number | 8115011 |
| Device Expiration Date | 2011-05-31 |
| 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 | 2011-06-17 |