MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-09-01 for BIOTESTCELL 3 816085100 manufactured by Bio-rad Medical Diagnostics Gmbh.
[2653075]
Customer reported that they missed an anti-jk (a) on their tango with biotestcell 3. The customer could send us neither the pt sample nor the complaint sample of biotestcell 3. The affected lot of biotestcell 3 (retention sample of quality control laboratory) was tested with an polyclonal anti-jk (a) and reacted correctly positive. Furthermore the affected lot of biotestcell 3 was tested with a two-fold serial dilution of the polyclonal anti-jk (a). The jk (a) positive cells of biotestcell 3 showed a "normal" expression of the jk (a) antigene.
Patient Sequence No: 1, Text Type: D, B5
[9845315]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610824-2010-00009 |
| MDR Report Key | 2571602 |
| Report Source | 05 |
| Date Received | 2010-09-01 |
| Date of Report | 2010-09-01 |
| Date of Event | 2010-08-06 |
| Date Mfgr Received | 2010-08-06 |
| Date Added to Maude | 2012-05-15 |
| 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 D-63303 |
| Manufacturer Country | GM |
| Manufacturer Postal | D-63303 |
| Manufacturer Phone | 103801528 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOTESTCELL 3 |
| Generic Name | REAGENT RED BLOOD CELLS |
| Product Code | LKJ |
| Date Received | 2010-09-01 |
| Catalog Number | 816085100 |
| Lot Number | 7027011 |
| Device Expiration Date | 2010-08-24 |
| 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 | 2010-09-01 |