MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-05-17 for BIOCLONE ANTI-HUMAN GLOBULIN 716980 manufactured by Ortho-clinical Diagnostics.
[647784]
A customer reported that a proficiency crossmatch was reported as compatible but the results should have been incompatible. Testing was performed with bioclone anti-human globulin lot rmg448c1. No death or serious injury was associated with this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2250051-2007-70240 |
| MDR Report Key | 872771 |
| Date Received | 2007-05-17 |
| Date of Report | 2007-05-17 |
| Date Added to Maude | 2007-06-29 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 | BIOCLONE ANTI-HUMAN GLOBULIN |
| Generic Name | ANTI-HUMAN GLOBULIN |
| Product Code | GMS |
| Date Received | 2007-05-17 |
| Model Number | NA |
| Catalog Number | 716980 |
| Lot Number | RMG448C1 |
| ID Number | NA |
| Device Expiration Date | 2008-02-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 853125 |
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS |
| Manufacturer Address | * RARITAN NJ 08869 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-05-17 |