HEA 1.2 BEADCHIP KIT, SLIDE 800-20202-08

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-19 for HEA 1.2 BEADCHIP KIT, SLIDE 800-20202-08 manufactured by Bioarray Solutions Ltd..

Event Text Entries

[140013001] Sequencing results interpretation: the molecular presence of both cytosine and thymine at the polymorphic site indicative of the ss antigen would normally represent a s+s+ individual,2. No other polymorphisms were observed that would explain the discrepancy however sequencing for other sites in the gypb gene were unresolvable which may be consistent with a hybrid or deletion event. Molecular events affecting expression, including gyp hybrids, are listed as limitations in the precise type hea molecular test package insert. [(b)(4)].
Patient Sequence No: 1, Text Type: N, H10


[140013002] The customer reported a possible discrepancy. The donor is s+ using the bioarray hea molecular beadchip kit; serology results were s-.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005967741-2019-00002
MDR Report Key8350804
Date Received2019-02-19
Date of Report2019-02-19
Date of Event2019-01-23
Date Mfgr Received2019-01-23
Device Manufacturer Date2018-07-11
Date Added to Maude2019-02-19
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 ContactMS. LUZ VILLAMIZAR
Manufacturer Street35 TECHNOLOGY DRIVE SUITE 100
Manufacturer CityWARREN NJ 07059
Manufacturer CountryUS
Manufacturer Postal07059
Manufacturer Phone9084449591
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameHEA 1.2 BEADCHIP KIT, SLIDE
Generic NameHEA 1.2 BEADCHIP KIT, SLIDE
Product CodePEP
Date Received2019-02-19
Model Number800-20202-08
Catalog Number800-20202-08
Lot Number19-1-V
Device Expiration Date2019-05-31
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBIOARRAY SOLUTIONS LTD.
Manufacturer Address35 TECHNOLOGY DRIVE SUITE 100 WARREN NJ 07059 US 07059


Patients

Patient NumberTreatmentOutcomeDate
10 2019-02-19

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