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 P3 816017 manufactured by Bio-rad Medical Diagnostics Gmbh.
[2202397]
The customer complained a false (b)(6) reaction of biotestcell-p3. We received neither the complained lot of biotestcell-p3 nor the affected sample of customer. When we received the complaint the reagent red blood cells were already expired. Therefore a testing of retention sample was not possible. At final serological control biotestcell-p3 was tested with different controls. All positive and negative reactions were correct. We didn't observe any false (b)(6) reactions. Summary: the testing quality control lab had confirmed the correct function of the complained lot of biotestcell-p3. 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 | 9610824-2011-00103 |
| MDR Report Key | 2209624 |
| Report Source | 05 |
| Date Received | 2011-08-03 |
| Date of Report | 2011-08-04 |
| Date of Event | 2011-07-07 |
| Date Mfgr Received | 2011-07-07 |
| 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 | INDUSTIESTRASSE 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 P3 |
| Generic Name | BIOTESTCELL P3 |
| Product Code | LKJ |
| Date Received | 2011-08-03 |
| Model Number | 816017 |
| Lot Number | 2121011 |
| Device Expiration Date | 2011-07-12 |
| 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 | INDUSTRIESTRASSE 1 DREIEICH D-63303 GM D-63303 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-08-03 |