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 2018-04-09 for CAPTURE-R READY INDICATOR RED CELLS 0006428 manufactured by Immucor, Inc..
[105377266]
The full number for the product in question is (b)(4) ((b)(4) 2003). Immucor technical support used a remote electronic connection method on (b)(4) 2018 to assess the instrument test well images in question which appeared as visually negative. An immucor field service engineer (fse) visited the customer site on 05mar2018 to assess the testing instrument and determined that the echo instrument is performing as expected with the exception of the camera module ability to appropriately identify some true positive results. Two (2) blood samples were returned from the customer site to the immucor laboratory for investigation, that were separated as red blood cells and plasma. The first blood sample was (b)(6), and was drawn on (b)(6) 2018. The second blood sample was (b)(6), and was drawn on (b)(6) 2018. The immucor laboratory investigation determined that the predominant nature of the antibody in question was igm. The presence of igg antibody could not be confirmed. Capture labeling states that the capture method of testing is designed to detect igg antibodies only, and not antibodies of igm in nature. Complaints of positive reactions being interpreted as negative by the galileo echo camera algorithm are being corrected under design control project 13-005. 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 tracking number for this report is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[105377267]
On (b)(6) 2018, it was determined that a customer site complaint reported on (b)(6) 2018 was deemed to be reportable because of an unexpectedly negative antibody screeen and identification when using capture-r ready indicator red cells by galileo echo method.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1034569-2018-00089 |
| MDR Report Key | 7407563 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-04-09 |
| Date of Report | 2018-04-09 |
| Date of Event | 2018-02-28 |
| Date Mfgr Received | 2018-02-28 |
| Date Added to Maude | 2018-04-09 |
| 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 | 2018-04-09 |
| Catalog Number | 0006428 |
| Lot Number | 221030 |
| Device Expiration Date | 2018-03-04 |
| 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 | 2018-04-09 |