MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-11-08 for 0.8% RESOLVE PANEL A 719501 manufactured by Ortho-clinical Diagnostics.
[761887]
A customer reported that a pt sample known to contain anti-c and anti-e did not react with multiple c negative, e positive cells of 0. 8% resolve panel a lot 8ra200. No death or serious injury is associated with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2250051-2006-50483 |
| MDR Report Key | 965124 |
| Date Received | 2006-11-08 |
| Date of Event | 2006-10-10 |
| Date Added to Maude | 2007-12-18 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 0.8% RESOLVE PANEL A |
| Generic Name | REAGENT RED BLOOD CELLS |
| Product Code | KZS |
| Date Received | 2006-11-08 |
| Model Number | NA |
| Catalog Number | 719501 |
| Lot Number | 8RA200 |
| ID Number | NA |
| Device Expiration Date | 2006-10-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 934789 |
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS |
| Manufacturer Address | * RARITAN NJ 08869 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-11-08 |