MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-04-18 for CAPTURE-MV * manufactured by Immucor, Inc..
[732375]
Customer reported, unexpected positive reactions with capture-cmv when testing 2 donor samples that previously tested negative. Repeat testing also resulted as negative. The samples tested positive for cmv antibodies by an alternative eia method. No adverse reactions occurred, however, one unit of ffp collected from one of the donors was released, but not transfused.
Patient Sequence No: 1, Text Type: D, B5
[7881621]
Returned and retention capture-cmv, lot c046 were tested with in-house donors of known cmv status. In-house donor samples cmv status was confirmed. Returned and retention products performed as expected. Customer did not return sample for investigation testing.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1034569-2007-00076 |
| MDR Report Key | 942634 |
| Report Source | 06 |
| Date Received | 2007-04-18 |
| Date of Report | 2007-04-18 |
| Date of Event | 2007-03-21 |
| Date Mfgr Received | 2007-03-21 |
| Date Added to Maude | 2007-11-14 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | SCOTT WEBER |
| Manufacturer Street | 3130 GATEWAY DRIVE |
| Manufacturer City | NORCROSS GA 30071 |
| Manufacturer Country | US |
| Manufacturer Postal | 30071 |
| Manufacturer Phone | 7704412051 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAPTURE-MV |
| Generic Name | MZE |
| Product Code | MZE |
| Date Received | 2007-04-18 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | C046 |
| ID Number | * |
| Device Expiration Date | 2007-07-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 914856 |
| Manufacturer | IMMUCOR, INC. |
| Manufacturer Address | * NORCROSS GA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-04-18 |