MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-04-08 for CAPTURE-R SELECT 0006446 manufactured by Immucor, Inc..
[20696708]
On (b)(6) 2014, a customer reported unexpected compatible crossmatch results when using capture-r select on a galileo neo instrument on (b)(6) 2014.
Patient Sequence No: 1, Text Type: D, B5
[21002372]
Immucor technical support used remote electronic access method to assess the galileo neo electronic images on (b)(4) 2014. The well images for the unexpected crossmatch compatible wells all appeared as unexpected negative with associated tightly defined red blood cell buttons. Immucor laboratory tested retention products on (b)(4) 2014 and all retention products performed as expected. The customer returned blood samples to immucor for testing, and on (b)(4) 2014 the immucor laboratory duplicated the unexpected compatible crossmatch results. The unexpected crossmatch compatible results have a potential for a transfusion error.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1034569-2014-00057 |
| MDR Report Key | 3734631 |
| Report Source | 05,06 |
| Date Received | 2014-04-08 |
| Date of Report | 2014-04-07 |
| Date of Event | 2014-03-11 |
| Date Mfgr Received | 2014-03-14 |
| Device Manufacturer Date | 2014-01-25 |
| Date Added to Maude | 2014-06-03 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR HOWARD YOREK |
| 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 | SOLID PHASE SYSTEM FOR THE IMMOBILIZATION OF HUMAN ERYTHROCYTES |
| Product Code | KSS |
| Date Received | 2014-04-08 |
| Catalog Number | 0006446 |
| Lot Number | SC262 |
| Device Expiration Date | 2015-01-25 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2014-04-08 |