MAUDE Adverse Event Report: BIOARRAY SOLUTIONS LTD. PRECISETYPE BEADCHIP TEST HEA; PRECISETYPE BEADCHIP TEST | HEA

Model Number 800-20202-08

Device Problem False Positive Result (1227)

Patient Problem No Information (3190)

Event Date 10/16/2014

Event Type  malfunction  

Event Description

Customer stated that a patient sample typed jkb+ by ivd hea assay, however, typed jkb by serology testing.This is a supplemental report for (b)(4).

Manufacturer Narrative

Package insert limitation: "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." in this case the patient was reported to be (b)(6) decent.Blood sample was sent for sequencing on (b)(6) 2014.Awaiting sequencing results.(b)(6) 2014 - sequencing results revealed that the sample had the jk null mutation, which is listed as a limitation in our precise type hea test as stated in the limitations section of the package insert.Above you will find a direct quotation from the limitation section of the package insert.Please refer to attached complaint report summary for details on sequencing results.

• Brand Name: PRECISETYPE BEADCHIP TEST HEA
• Type of Device: PRECISETYPE BEADCHIP TEST | HEA
• Manufacturer (Section D): BIOARRAY SOLUTIONS LTD.; 35 technology drive; suite 100; warren NJ 07059
• Manufacturer Contact: peter scott ; 35 technology drive; suite 100; warren, NJ 07059 ; 9084449578
• MDR Report Key: 4303862
• MDR Text Key: 5085911
• Report Number: 3005967741-2014-00002
• Device Sequence Number: 1
• Product Code: PEP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BP130026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 12/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2014
• Device Model Number: 800-20202-08
• Device Catalogue Number: 800-20202-08
• Device Lot Number: 14-54
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/08/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1