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 company representative,health report with the FDA on 2018-02-02 for CAPTURE-R READY INDICATOR RED CELLS 0006428 manufactured by Immucor, Inc..

Event Text Entries

[99771682] The full number for the product in question is bk020053 ((b)(4) 2003). Immucor technical support used a remote elctronic connection method on (b)(4) 2018 to assess the instrument test well image in question, and determined that the instrument test well images in question were consistent with the instrument interpretation.
Patient Sequence No: 1, Text Type: N, H10


[99771683] On (b)(6) 2017, an immucor employee visiting a customer site reported an unexpected 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


MAUDE Entry Details

Report Number1034569-2018-00027
MDR Report Key7235327
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2018-02-02
Date of Report2018-02-01
Date of Event2018-01-08
Date Mfgr Received2018-01-10
Date Added to Maude2018-02-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
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 NameANTIGLOBULIN COATED RED CELLS
Product CodeKSF
Date Received2018-02-02
Catalog Number0006428
Lot Number221010
Device Expiration Date2018-01-21
OperatorMEDICAL TECHNOLOGIST
Device AvailabilityN
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 2018-02-02

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