MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-11-01 for CAPTURE-R READY INDICATOR RED CELLS 0006428 manufactured by Immucor, Inc..
[127383027]
The full number for the product in question is bk020053 (january 27, 2003). Immucor technical support used a remote electronic connection method on (b)(6) 2018 to assess the testing instrument in question. The immucor laboratory had previously tested retention product on (b)(6) 2018, which performed as expected at that time. The internal immucor record tracking number for this record is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[127383028]
On (b)(6) 2018, an immucor employee reported to immucor technical support, on behalf of a customer site, an unexpectedly negative antibody screen when using capture-r ready indicator red cells on a galileo neo instrument, when tested on (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1034569-2018-00248 |
| MDR Report Key | 8029563 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-11-01 |
| Date of Report | 2018-11-01 |
| Date of Event | 2018-09-10 |
| Date Mfgr Received | 2018-10-10 |
| Date Added to Maude | 2018-11-01 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2018-11-01 |
| Catalog Number | 0006428 |
| Lot Number | 221158 |
| Device Expiration Date | 2018-09-20 |
| 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 | 2018-11-01 |