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.
[2201893]
The customer complained false negative reactions of a d positive control sample with cell 1 of biotestcell 3. Customer had sent neither the complained lot of biotestcell 3 nor the control.
Patient Sequence No: 1, Text Type: D, B5
[9219597]
Summary: the review of the batch record documentation showed no irregularities which might have affected negatively the quality of the complained lot. Due to the confirmed complaint a risk analysis was performed. On the basis of the result of the risk analysis we decided that no market related activities are necessary. A capa has been initiated to intensify the efforts to find the root cause for the complaint.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610824-2011-00097 |
| MDR Report Key | 2209595 |
| Report Source | 05 |
| Date Received | 2011-08-03 |
| Date of Report | 2011-08-04 |
| Date of Event | 2011-07-06 |
| Date Mfgr Received | 2011-07-06 |
| Date Added to Maude | 2012-05-11 |
| 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 | 8123011 |
| 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 | INDUSTRIESTRASSE 1 DREIEICH D-63303 GM D-63303 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-08-03 |