MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-03-04 for BLOOD GROUPING REAGENT ANTI-S (MNS3) 808052100 manufactured by Bio-rad Medical Diagnostics Gmbh.
[1953623]
The customer reported a false negative reaction of a blood donor with seraclone anti-s.
Patient Sequence No: 1, Text Type: D, B5
[9091324]
The testing of the quality control laboratory confirmed the correct function of the affected lot of seraclone anti-s. The review of the batch record documentation showed no irregularities which might have affected negatively the quality of the complained lots.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610824-2011-00027 |
| MDR Report Key | 2024232 |
| Report Source | 05 |
| Date Received | 2011-03-04 |
| Date of Report | 2011-03-03 |
| Date of Event | 2011-02-07 |
| Date Mfgr Received | 2011-02-08 |
| Date Added to Maude | 2011-06-15 |
| 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 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 | BLOOD GROUPING REAGENT ANTI-S (MNS3) |
| Generic Name | SERACLONE ANTI-S (MNS3) |
| Product Code | LKJ |
| Date Received | 2011-03-04 |
| Returned To Mfg | 2011-02-14 |
| Catalog Number | 808052100 |
| Lot Number | 7025110-01 |
| Device Expiration Date | 2012-06-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2011-03-04 |