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 2017-11-13 for CAPTURE-R READY INDICATOR RED CELLS 0006428 manufactured by Immucor, Inc..

Event Text Entries

[93056011] The full number for the product in question is pma/510 (k)# bk020053 (1/27/03). Immucor technical support used a remote electronic connection method on (b)(6) 2017 to assess the instrument test well image in question, and determined that the instrument test well image in question was visually negative. An immucor field service engineer visited the customer site to assess the testing instrument used on (b)(6) 2017 and found it to be operating as expected.
Patient Sequence No: 1, Text Type: N, H10


[93056012] On (b)(6) 2017, a (b)(6) customer site reported an unexpected negative antibody screen 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 Number1034569-2017-00303
MDR Report Key7024774
Date Received2017-11-13
Date of Report2017-11-13
Date of Event2017-10-14
Date Mfgr Received2017-10-15
Date Added to Maude2017-11-13
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 Received2017-11-13
Catalog Number0006428
Lot Number221957
Device Expiration Date2017-10-29
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 2017-11-13

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