MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2008-09-24 for CAPTURE-R SELECT manufactured by Immucor, Inc..
[963964]
During galileo validation, unexpected negative reactions were observed using capture-r select. Eighty donors were tested and half of them demonstrated positive reactivity when tested with a serum know to contain anti-vel.
Patient Sequence No: 1, Text Type: D, B5
[8193998]
The customer returned a sample (reported to contain anti-vel), it was tested with panoscreen, lot 28317, using immuadd as the potentiator. Incubations at is and rt were included. No reactivity was observed at is or rt. Variable reactivity was observed at iat. The customer's sample was also tested with capture-r ready screen (crrs), lot g140, and capture-r select, lot sc050. The sample was reactive with cell iv on crrs. The sample was reactive with all cells on select, lot sc050. No vel-negative donor cells were available for testing. The customer did not return product for investigation, the results appear to be due to the nature of the sample.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1034569-2008-00472 |
| MDR Report Key | 1171475 |
| Report Source | 01,05,06 |
| Date Received | 2008-09-24 |
| Date of Report | 2008-09-24 |
| Date of Event | 2008-09-01 |
| Date Mfgr Received | 2008-09-01 |
| Date Added to Maude | 2008-09-25 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. J. SCOTT WEBBER |
| Manufacturer Street | 3130 GATEWAY DRIVE |
| Manufacturer City | NORCROSS GA 30071 |
| Manufacturer Country | US |
| Manufacturer Postal | 30071 |
| Manufacturer Phone | 7704412051 |
| Manufacturer G1 | IMMUCOR, INC. |
| Manufacturer Street | 3130 GATEWAY DRIVE |
| Manufacturer City | NORCROSS GA 30071 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30071 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAPTURE-R SELECT |
| Generic Name | SOLID PHASE RED CELL ADHERENCE ASSAY |
| Product Code | KSS |
| Date Received | 2008-09-24 |
| Lot Number | SC050 |
| Device Expiration Date | 2006-11-30 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1196768 |
| Manufacturer | IMMUCOR, INC. |
| Manufacturer Address | 3130 GATEWAY DRIVE NORCROSS GA 30071 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-09-24 |