MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-05-21 for CAPTURE-R READY-ID 0066214 manufactured by Immucor, Inc..
[145778659]
On may 16, 2019 immucor tested the customer sample (id (b)(6)) and an in-house known anti-kpa positive and anti-kpa negative with a retention capture-r ready-id lot number id378. The in-house samples reacted as expected, but the customer sample was still unexpectedly negative with all cells. The immucor internal report record number for this report is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[145778660]
On (b)(6) 2019 a customer in (b)(6) reported unexpected negative results with capture-r ready-id on the eu version of galileo neo instrument.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1034569-2019-00100 |
| MDR Report Key | 8628897 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-05-21 |
| Date of Report | 2019-05-21 |
| Date of Event | 2019-05-04 |
| Date Mfgr Received | 2019-05-06 |
| Date Added to Maude | 2019-05-21 |
| 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-ID |
| Generic Name | REAGENT RED BLOOD CELLS |
| Product Code | KSF |
| Date Received | 2019-05-21 |
| Catalog Number | 0066214 |
| Lot Number | ID378 |
| Device Expiration Date | 2019-06-25 |
| 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 | 2019-05-21 |