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 with the FDA on 2017-07-05 for CAPTURE-R READY INDICATOR RED CELLS 0006428 manufactured by Immucor, Inc..

Event Text Entries

[79247832] The full number for the product in question is bk020053 (1/27/03). The product had already expired when the customer called to report the event, but the immucor laboratory performed a dhr review on 15jun2017, which showed that the product was acceptable before the product was released to market. Immucor technical support used a remote electronic connection method on (b)(6) 2017 to assess the instrument test well images in question, and determined that the instrument test well images in question were visually negative.
Patient Sequence No: 1, Text Type: N, H10


[79247833] On (b)(6) 2017, a customer site reported an unexpected negative antibody identification when using capture-r ready indicator red cells on a galileo echo instrument, when tested on (b)(6) 2017.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1034569-2017-00126
MDR Report Key6686380
Date Received2017-07-05
Date of Report2017-07-05
Date of Event2017-05-19
Date Mfgr Received2017-06-09
Date Added to Maude2017-07-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationMEDICAL TECHNOLOGIST
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 Report0

Device Details

Brand NameCAPTURE-R READY INDICATOR RED CELLS
Generic NameANTIGLOBULIN COATED RED CELLS
Product CodeKSF
Date Received2017-07-05
Catalog Number0006428
Lot Number221859
Device Expiration Date2017-06-08
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 2017-07-05

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