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 2018-04-19 for CAPTURE-R READY INDICATOR RED CELLS 0006428 manufactured by Immucor, Inc..

Event Text Entries

[106841719] The full number for the product in question is (b)(4) (1/27/2003). Immucor technical support used a remote electronic connection method on (b)(6) 2018 to assess the instrument test well images in question, of which some appeared as visually positive (homozygous m antigen expression test wells) and some appeared as visually negative (heterozygous m antigen expression test wells). The immucor laboratory tested retention product on (b)(6) 2018, which performed as expected. Complaints of positive reactions being interpreted as negative by the galileo echo camera algorithm are being corrected under design control project 13-005. The immucor technical communication cc-09-042-02 is being used by the lab to visually confirm all negative assay events reported by the echo instrument. The internal immucor tracking number for this report is (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[106841720] On (b)(6) 2018, a customer site reported an unexpectedly negative antibody screen when using capture-r ready indicator red cells by galileo echo method.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1034569-2018-00100
MDR Report Key7443133
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2018-04-19
Date of Report2018-04-19
Date of Event2018-03-27
Date Mfgr Received2018-03-27
Date Added to Maude2018-04-19
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 Report3

Device Details

Brand NameCAPTURE-R READY INDICATOR RED CELLS
Generic NameANTIGLOBULIN COATED RED CELLS
Product CodeKSF
Date Received2018-04-19
Catalog Number0006428
Lot Number221056
Device Expiration Date2018-04-15
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 2018-04-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.