MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-01-09 for ANTI-D BIOCLONE 717380 manufactured by Ortho-clinical Diagnostics.
[3281269]
Customer reported that a pt, previously typed as weak d negative, returned to the facility one week later and a 3+ reaction was observed at immediate spin. Customer stated that quality control testing had been satisfactory at both times. No death or serious injury was associated with this incident. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10502313]
Ortho-clinical diagnostics (ocd) qa performed retained testing. D+, weak d+, and d- cells reacted as expected. Results were satisfactory.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2250051-2008-00020 |
| MDR Report Key | 2948681 |
| Report Source | 05 |
| Date Received | 2008-01-09 |
| Date of Report | 2008-01-09 |
| Date of Event | 2007-12-04 |
| Date Mfgr Received | 2007-12-13 |
| Device Manufacturer Date | 2007-03-01 |
| Date Added to Maude | 2013-02-08 |
| 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 | JENNIFER SPARROW |
| Manufacturer Street | 1001 US HWY 202 |
| Manufacturer City | RARITAN NJ 08869 |
| Manufacturer Country | US |
| Manufacturer Postal | 08869 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANTI-D BIOCLONE |
| Generic Name | BLOOD GROUPING REAGENT |
| Product Code | DGR |
| Date Received | 2008-01-09 |
| Model Number | NA |
| Catalog Number | 717380 |
| Lot Number | DB265A |
| ID Number | NA |
| Device Expiration Date | 2009-03-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS |
| Manufacturer Address | RARITAN NJ 08869 US 08869 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-01-09 |