CAPTURE-R READY INDICATOR RED CELLS 0006428

MAUDE Adverse Event Report

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..

Event Text Entries

[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


MAUDE Entry Details

Report Number1034569-2019-00080
MDR Report Key8540049
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2019-04-23
Date of Report2019-04-23
Date of Event2019-03-26
Date Mfgr Received2019-03-29
Date Added to Maude2019-04-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR HOWARD YOREK
Manufacturer Street3130 GATEWAY DRIVE
Manufacturer CityNORCROSS GA 300915625
Manufacturer CountryUS
Manufacturer Postal300915625
Manufacturer Phone7704412051
Manufacturer G1IMMUCOR, INC.
Manufacturer Street3130 GATEWAY DRIVE
Manufacturer CityNORCROSS GA 300915625
Manufacturer CountryUS
Manufacturer Postal Code300915625
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCAPTURE-R READY INDICATOR RED CELLS
Generic NameKIT, QUALITY CONTROL FOR BLOOD BANKING REAGENTS
Product CodeKSF
Date Received2019-04-23
Catalog Number0006428
Device Expiration Date2019-03-31
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerIMMUCOR, INC.
Manufacturer Address3130 GATEWAY DRIVE NORCROSS GA 300915625 US 300915625


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-23

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