MAUDE Adverse Event Report: BIOARRAY SOLUTIONS PRECISETYPE HEA MOLECULAR BEADCHIP TEST; MOLECULIAR ERYTHROCYTE TYPING TEST

Model Number	800-20202-08
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the beadchip (b)(4) (performed on (b)(6) 2021), the result for the kidd system depicted as jka-jkb+.Besides, customer performed the sample testing with different molecular platform, which is rt-pcr, it showed jkb - (b)(4).
Event or Problem Description
On (b)(6) 2021 a customer reported discrepancy in detecting jkb antigen using beadchip((b)(4)) and requested assistance.
Additional Manufacturer Narrative
Sanger sequencing determine that the individual is homozygous for jkb, jk (a-b+) as reported by hea beadchip.However, the individual is also positive for a polymorphism known for weakening expression of the jkb antigen, jk(b+w).In addition, the individual is also homozygous for a polymorphism which is a known silencing mutation that inhibits expression of jk antigens on red blood cells; therefore, the jk(a-b-) results by serology.This limitation is addressed in the package insert: false positive and/or invalid results may be generated in rare cases where a sample contains examples of molecular events that affect the blood-group antigen expression and phenotypes and the nucleotide changes associated with these events are not explicitly monitored by the assay.Examples include dna-sequence variations including premature stop codon, snp leading to missense change in amino acid, hybrid genes, modifying genes; changes at the rna transcription level including alternative splicing; reduced protein expression, etc.Known phenotypes are knull, jknull (jknull has a prevalence of up to 9% among polynesians), rhnull, rh hybrids, kmod, co (a-,b-), in(lu), lu (a-,b-) and gp hybrids.Presence of a c.179_180del (ser60fs) mutation linked with the fy(b) allele may change the fy(b) antigen expression and lead to a false positive result.

• Brand Name: PRECISETYPE HEA MOLECULAR BEADCHIP TEST
• Common Device Name: MOLECULIAR ERYTHROCYTE TYPING TEST
• Manufacturer (Section D): BIOARRAY SOLUTIONS; 35 technology drive, suite 100; warren NJ 07059
• Manufacturer (Section G): BIOARRAY SOLUTIONS; 35 technology drive, suite 100; warren NJ 07059
• Manufacturer Contact: howard yorek ; 35 technology drive, suite 100; warren, NJ 07059 ; 6784184738
• MDR Report Key: 12972702
• Report Number: 3005967741-2021-00007
• Device Sequence Number: 4217004
• Product Code: PEP
• UDI-Device Identifier: 10888234100065
• UDI-Public: 10888234100065
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: BP130026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/30/2022
• Device Model Number: 800-20202-08
• Device Catalogue Number: 800-20202-08
• Device Lot Number: 21-105-V
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2021
• Supplement Date Received by Manufacturer: 02/16/2022
• Initial Report FDA Received Date: 12/09/2021
• Supplement Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown