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 2018-05-22 for CAPTURE-R SELECT 0006446 manufactured by Immucor, Inc..
[109002626]
Immucor technical support used a remote electronic connection method on (b)(6) 2018 to assess the instrument test well images in question, and determined that the instrument test well images in question were visually negative. A review of the event logs showed no errors during testing on (b)(6) 2018, and the camera images were aligned and focused. An immucor field service engineer visited the customer site to assess the testing instrument used on (b)(6) 2018 and found it to be operating as expected. Complaints of positive reactions being interpreted as negative by the galileo echo camera algorithm are being corrected under design control project 13-005. 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. The internal immucor record tracking number is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[109002627]
On (b)(6) 2018, a customer site reported an unexpectedly negative compatible crossmatch when using capture-r select strips on a galileo echo instrument, when tested on (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1034569-2018-00124 |
| MDR Report Key | 7534667 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-05-22 |
| Date of Report | 2018-05-22 |
| Date of Event | 2018-04-09 |
| Date Mfgr Received | 2018-04-30 |
| Date Added to Maude | 2018-05-22 |
| 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 | 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 SELECT |
| Generic Name | SOLID PHASE SYSTEM FOR THE IMMOBILIZATION OF HUMAN ERYTHROCYTES |
| Product Code | KSF |
| Date Received | 2018-05-22 |
| Catalog Number | 0006446 |
| Lot Number | SC551 |
| Device Expiration Date | 2019-01-28 |
| 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 300915625 US 300915625 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-22 |