MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-04-27 for CAPTURE-CMV * manufactured by Immucor.
[20897339]
Customer reported unexpected positive reactions with capture cmv on donor samples. The unexpected positive reactions were observed in donor samples that previously tested negative.
Patient Sequence No: 1, Text Type: D, B5
[21180872]
Customer returned samples for testing. Samples were tested with retention capture cmv, lot c047. In-house donor samples of known cmv status were also included in the testing. The customer's samples exhibited positive reactivity. In-house donor samples reacted as expected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1034569-2007-00094 |
| MDR Report Key | 956365 |
| Report Source | 06 |
| Date Received | 2007-04-27 |
| Date of Report | 2007-04-27 |
| Date of Event | 2007-04-04 |
| Date Mfgr Received | 2007-04-04 |
| Date Added to Maude | 2007-12-03 |
| 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-CMV |
| Generic Name | MZE |
| Product Code | MZE |
| Date Received | 2007-04-27 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | C047 |
| ID Number | * |
| Device Expiration Date | 2007-08-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 927041 |
| Manufacturer | IMMUCOR |
| Manufacturer Address | * NORCROSS GA 30091 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-04-27 |