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 2018-05-25 for CAPTURE-R READY INDICATOR RED CELLS 0006428 manufactured by Immucor, Inc..
[109747218]
The full number for the product in question is bk020053 (1/27/03). Immucor technical support used a remote electronic connection method to assess the instrument test well images in question on 01may2018, which visually appeared positive. A review of the check image well showed a bubble in the 3rd screening well, and the event log showed that there was a warning for the reagent in question of a remaining liquid volume lower than expected. The immucor laboratory tested retention product on 17may2018 and 21may2018 against antibody screen strip r969, which performed as expected. Complaints of positive reactions being interpreted as negative by the galileo echo camera algorithm are being corrected under design control project (b)(4). The echo instrument is performing as expected with the exception of the camera module ability to appropriately identify some true positive results. The immucor technical communication (b)(4) is being used by the lab to visually confirm all negative assay events reported by the echo instrument. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[109747219]
On (b)(6) 2018, a customer site reported an unexpected negative antibody screen when using capture-r ready indicator red cells by galileo echo.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1034569-2018-00127 |
| MDR Report Key | 7545105 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-05-25 |
| Date of Report | 2018-05-25 |
| Date of Event | 2018-05-01 |
| Date Mfgr Received | 2018-05-01 |
| Date Added to Maude | 2018-05-25 |
| 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 | 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 | 2018-05-25 |
| 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 | 2018-05-25 |