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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOARRAY SOLUTIONS LTD. HEA 1.2 BEADCHIP KIT, SLIDE

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BIOARRAY SOLUTIONS LTD. HEA 1.2 BEADCHIP KIT, SLIDE Back to Search Results
Model Number 800-20202-08
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/26/2017
Event Type  malfunction  
Manufacturer Narrative
Sequencing interpretation: the molecular presence of only adenine at the polymorphic site that is indicative of the kidd (jk) antigen would normally represent a homozygous jkb individual1, as was reported on hea beadchip carrier heae0954_1.However, the individual is also homozygous for a polymorphism of the intron 5 splice acceptor site (ivs5as, isbt=jk*02n.01, also known as c.342-1g>a) that silences the expression of the jkb antigen.The silencing of jkb, as first reported by lucien et al.2, would leave no expression of the jkb antigen on the surface of the erythrocyte.Jknull is listed as a limitation of the precisetype¿ hea beadchip test as listed in the package insert (part number 190-20210).
 
Event Description
The customer reported a possible discrepancy.The donor is jkb+ using the bioarray hea molecular beadchip kit; serology results were jkb-.
 
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Brand Name
HEA 1.2 BEADCHIP KIT, SLIDE
Type of Device
HEA 1.2 BEADCHIP KIT, SLIDE
Manufacturer (Section D)
BIOARRAY SOLUTIONS LTD.
35 technology drive
suite 100
warren NJ 07059
Manufacturer Contact
luz villamizar
35 technology drive
suite 100
warren, NJ 07059
9084449591
MDR Report Key6977339
MDR Text Key91086832
Report Number3005967741-2017-00026
Device Sequence Number1
Product Code PEP
UDI-Device Identifier10888234100065
UDI-Public10888234100065
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
BP130026
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Medical Technologist
Type of Report Initial
Report Date 10/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date12/31/2017
Device Model Number800-20202-08
Device Catalogue Number800-20202-08
Device Lot Number17-140-V
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/26/2017
Initial Date FDA Received10/25/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/07/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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