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 2019-04-23 for CAPTURE-R READY INDICATOR RED CELLS 0006428 manufactured by Immucor, Inc..
[142895351]
On (b)(6) 2019 immucor technical support used a remote electronic connection method to assess files on echo lumena instrument serial number (b)(4); the camera report and the event log were both acceptable. On (b)(6) 2019 an immucor technical services explained to the customer that the patient sample cannot be ruled out as the cause due to fact that the xm was compatible on both echos, and with the gel and tube methods. The immucor internal report record number for this report is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[142895352]
On (b)(6) 2019 a customer reported unexpected negative results for a crossmatch on the echo lumena instrument.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1034569-2019-00080 |
| MDR Report Key | 8540049 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-04-23 |
| Date of Report | 2019-04-23 |
| Date of Event | 2019-03-26 |
| Date Mfgr Received | 2019-03-29 |
| Date Added to Maude | 2019-04-23 |
| 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 | KIT, QUALITY CONTROL FOR BLOOD BANKING REAGENTS |
| Product Code | KSF |
| Date Received | 2019-04-23 |
| Catalog Number | 0006428 |
| Device Expiration Date | 2019-03-31 |
| 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 | 2019-04-23 |