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 2018-04-19 for CAPTURE-R READY INDICATOR RED CELLS 0006428 manufactured by Immucor, Inc..
[106841719]
The full number for the product in question is (b)(4) (1/27/2003). Immucor technical support used a remote electronic connection method on (b)(6) 2018 to assess the instrument test well images in question, of which some appeared as visually positive (homozygous m antigen expression test wells) and some appeared as visually negative (heterozygous m antigen expression test wells). The immucor laboratory tested retention product on (b)(6) 2018, 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 13-005. The immucor technical communication cc-09-042-02 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
[106841720]
On (b)(6) 2018, a customer site reported an unexpectedly negative antibody screen when using capture-r ready indicator red cells by galileo echo method.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1034569-2018-00100 |
| MDR Report Key | 7443133 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-04-19 |
| Date of Report | 2018-04-19 |
| Date of Event | 2018-03-27 |
| Date Mfgr Received | 2018-03-27 |
| Date Added to Maude | 2018-04-19 |
| 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 | 2018-04-19 |
| Catalog Number | 0006428 |
| Lot Number | 221056 |
| Device Expiration Date | 2018-04-15 |
| 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 | 2018-04-19 |