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 2012-11-21 for CAPTURE-R SELECT 0006446 manufactured by Immucor, Inc..
[21402255]
The customers submitted sample resulted as positive (2+ incompatible) with three submitted donor samples and invalid with one submitted donor sample due to a monolayer failure. Known anti-jkb positive and negative samples were crossmatched with the four submitted donor samples and the expected positive (3+) and negative results were obtained. The crossmatch assay was repeated three more times with the submitted sample; it was not possible to obtain a crossmatch result for sample (b)(4) with donor (b)(6) due to monolayer failures.
Patient Sequence No: 1, Text Type: N, H10
[21415103]
A customer reported obtaining an unexpected negative reaction with the crossmatch assay with a known anti-jkb sample.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1034569-2012-00215 |
| MDR Report Key | 2841353 |
| Report Source | 01,05,06 |
| Date Received | 2012-11-21 |
| Date of Report | 2012-11-21 |
| Date of Event | 2012-10-04 |
| Date Mfgr Received | 2012-10-24 |
| Device Manufacturer Date | 2012-06-10 |
| Date Added to Maude | 2013-02-22 |
| 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 SCOTT WEBBER |
| Manufacturer Street | 3130 GATEWAY DRIVE |
| Manufacturer City | NORCROSS GA 300915625 |
| Manufacturer Country | US |
| Manufacturer Postal | 300915625 |
| Manufacturer Phone | 7704412051 |
| Manufacturer G1 | IMMUCOR, INC. |
| Manufacturer Street | 3130 GATEWAY DRIVE |
| Manufacturer City | NORCROSS GA 30091562 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30091 5625 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAPTURE-R SELECT |
| Generic Name | BLOOD BANK SUPPLY |
| Product Code | KSS |
| Date Received | 2012-11-21 |
| Catalog Number | 0006446 |
| Lot Number | SC208 |
| Device Expiration Date | 2013-06-10 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMMUCOR, INC. |
| Manufacturer Address | 3130 GATEWAY DRIVE NORCROSS GA 30091562 US 30091 5625 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-11-21 |