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 2019-04-26 for CAPTURE-R READY INDICATOR RED CELLS 0006428 manufactured by Immucor, Inc..
[145778068]
On april 15, 2019 immucor technical support used a remote electronic connection method to assess files on galileo echo v2 instrument serial number (b)(4); the camera report was acceptable and the event log indicated no errors at time of testing. Unable to rule out capture-r ready indicator red cells lot number 221291 as testing done april 15, 2019 used a different lot cric than the testing done april 3, 2019; however, the anti-e is showing dosage as heterozygous e cells are not reacting. On april 16, 2019 an immucor field service technician inspected galileo echo v2 instrument serial number (b)(4) at the customer facility. The technician found the instrument operational and performed a successful unexpected reaction checklist. Found instrument to be fully operational and to be operating in specification. The immucor internal report record number for this report is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[145778069]
On (b)(6) 2019 a customer reported an unexpected negative result for a screen assay on a galileo echo v2 instrument.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1034569-2019-00088 |
| MDR Report Key | 8558105 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-04-26 |
| Date of Report | 2019-04-26 |
| Date of Event | 2019-04-03 |
| Date Mfgr Received | 2019-04-15 |
| Date Added to Maude | 2019-04-26 |
| 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 | QUALITY CONTROL KITS FOR BLOOD BANKING REAGENTS |
| Product Code | KSF |
| Date Received | 2019-04-26 |
| Catalog Number | 0006428 |
| Lot Number | 221291 |
| Device Expiration Date | 2019-04-14 |
| 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 | 2019-04-26 |