MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-08-03 for REAGENT RED BLOOD CELLS BIOTESTCELL 3 816085100 manufactured by Bio-rad Medical Diagnostics Gmbh.
[2202396]
The customer complained (b)(6) reactions with cell 2 of biotestcell 3. We received neither the affected samples nor the complained lot of biotestcell 3. Therefore the retention sample was tested with (b)(6) control and different plasma samples. All (b)(6) reactions were correct. We didn't observe any (b)(6) reactions. Summary: the testing quality control lab had confirmed the correct function of the complained lot of biotestcell 3. The review of the batch record documentation showed no irregularities which might have affected negatively the quality of the complained lot.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610824-2011-00104 |
| MDR Report Key | 2209622 |
| Report Source | 05 |
| Date Received | 2011-08-03 |
| Date of Report | 2011-08-04 |
| Date of Event | 2011-07-05 |
| Date Mfgr Received | 2011-07-06 |
| 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 |
| 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 | 2011-08-03 |
| Catalog Number | 816085100 |
| Lot Number | 8123021 |
| Device Expiration Date | 2011-07-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIO-RAD MEDICAL DIAGNOSTICS GMBH |
| Manufacturer Address | INDUSTIESTRASSE 1 DREIEICH D-63303 GM D-63303 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-08-03 |