MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-11 for CAPTURE-R READY INDICATOR RED CELLS 0006428 manufactured by Immucor, Inc..
[95790557]
The full number for the product in question is (b)(4) (1/27/03). Immucor technical support used a remote electronic connection method on 29nov2017 to assess the instrument test well images in question, and determined that the instrument test well images in question were visually weak positive. An immucor field service engineer (fse) visited the customer site to assess the testing instrument used on 30nov2017 and found that 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.
Patient Sequence No: 1, Text Type: N, H10
[95790558]
On (b)(6) 2017, a customer site reported an unexpected negative antibody identification when using capture-r ready indicator red cells on a galileo echo instrument.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1034569-2017-00333 |
| MDR Report Key | 7105829 |
| Date Received | 2017-12-11 |
| Date of Report | 2017-12-11 |
| Date of Event | 2017-11-15 |
| Date Mfgr Received | 2017-11-15 |
| Date Added to Maude | 2017-12-11 |
| 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 | 0 |
| Brand Name | CAPTURE-R READY INDICATOR RED CELLS |
| Generic Name | ANTIGLOBULIN COATED RED CELLS |
| Product Code | KSF |
| Date Received | 2017-12-11 |
| Catalog Number | 0006428 |
| Lot Number | 221961 |
| Device Expiration Date | 2017-11-19 |
| 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 | 2017-12-11 |