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 2019-01-18 for CAPTURE-R READY INDICATOR RED CELLS 0006428 manufactured by Immucor, Inc..
[133939450]
The full number for the product in question is (b)(4) (1/27/2003). Immucor technical support used a remote electronic connection method on 04jan2019 to assess the testing instrument in question. The instrument test well images in question were visually negative, the camera calibration was in range and the event log showed no relevant information. Because the product was already expired at the time of immucor being made aware of this situation, the immucor laboratory determined that retention testing had previously already been performed when the product was in-date, but not on an echo lumena instrument, but rather a galileo echo instrument, and at that time, under those circumstances, the retention product performed as expected. The internal immucor record tracking number for this record is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[133939451]
On (b)(6) 2019, a customer site reported an unexpectedly negative antibody screen when using capture-r ready indicator red cells on an echo lumena instrument, when tested on (b)(6) 2018, which led to an event being categorized as a delayed hemolytic transfusion reaction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1034569-2019-00029 |
| MDR Report Key | 8261112 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-01-18 |
| Date of Report | 2019-01-18 |
| Date of Event | 2018-12-17 |
| Date Mfgr Received | 2019-01-04 |
| Date Added to Maude | 2019-01-18 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2019-01-18 |
| Catalog Number | 0006428 |
| Lot Number | 221216 |
| Device Expiration Date | 2018-12-23 |
| 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 | 1. Other | 2019-01-18 |