• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIOARRAY SOLUTIONS LTD. HEA 1.2 BEADCHIP KIT, PLATE 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 07/15/2020
Event Type  malfunction  
Manufacturer Narrative
Interpretation: the molecular presence of guanine and adenine at the polymorphic site that is indicative of the kidd (jk) antigen represents a heterozygous jk(a+b+) individual 1, as was reported by hea beadchips (b)(4)_7 and (b)(4)_7.However, the individual is also homozygous for a polymorphism at c.588a>g in exon 6 (rs2298718) that could weaken the expression of the jka and jkb antigens2,3,4.Using sequence-specific primer pcr and bi-directional sanger sequencing analysis, this individual is c.28g in exon 3, c.226g and c.303g in exon 4, and c.588a in exon 6 demonstrating lack of the jk*01n.20 [jk(a-b-)] variant5.This is a case where a sample contains a molecular event that affect the blood-group antigen expression, and the nucleotide changes associated with this event are not explicitly monitored by the hea assay as described in the package insert (part number 190-20210).(b)(4).
 
Event Description
The customer reported a possible discrepancy.The donor is jka+ using the bioarray hea molecular beadchip kit; serology results were jka-.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HEA 1.2 BEADCHIP KIT, PLATE
Type of Device
HEA 1.2 BEADCHIP KIT, PLATE
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 Key10368052
MDR Text Key205290436
Report Number3005967741-2020-00004
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 Other
Type of Report Initial
Report Date 08/05/2020
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 Date07/31/2020
Device Model Number800-20202-08
Device Catalogue Number800-20202-08
Device Lot Number19-137-V
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 07/15/2020
Initial Date FDA Received08/05/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
-
-