MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-05-29 for CAPTURE-R READY INDICATOR RED CELLS 0006428 manufactured by Immucor, Inc..
[109487059]
The full number for the product in question is (b)(4). Immucor technical support used a remote electronic connection method to assess the instrument test well images in question which visually appeared as tight buttons, with the button intact. The immucor laboratory tested retention product on (b)(6) 2018 which performed as expected. The immucor laboratory also tested a returned blood sample by various methods. This returned blood sample ((b)(4)) was a thawed previously-frozen plasma sample which was drawn 11/10. This sample was tested against retention product on (b)(6) 2018, which yielded unexpected negative outcomes, consistent with the customer's findings. The customer issue was reproduced with the returned sample. The returned blood sample was also tested by manual test tube method on (b)(6) 2018, using panocreen lot number 16248, combined with both immuadd (lot number 357018-1) and also gamma peg (lot number 336032) as enhancement, and both sets of manual tests yielded expected positive outcomes, consistent with what the customer reported. The internal immucor record number for this report is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[109487060]
On (b)(6) 2018, a customer site reported an unexpected negative antibody screen when using capture-r ready indicator red cells by galileo echo, when tested on (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1034569-2018-00130 |
| MDR Report Key | 7550727 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-05-29 |
| Date of Report | 2018-05-29 |
| Date of Event | 2018-05-09 |
| Date Mfgr Received | 2018-05-10 |
| Date Added to Maude | 2018-05-29 |
| 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 | 3 |
| Event Location | 3 |
| 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 300915625 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 300915625 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAPTURE-R READY INDICATOR RED CELLS |
| Generic Name | ANTIGLOBULIN COATED RED CELLS |
| Product Code | KSF |
| Date Received | 2018-05-29 |
| Catalog Number | 0006428 |
| Lot Number | 221081 |
| Device Expiration Date | 2018-05-20 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMMUCOR, INC. |
| Manufacturer Address | 3130 GATEWAY DRIVE NORCROSS GA 300915625 US 300915625 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-29 |