MAUDE Adverse Event Report: BIOARRAY SOLUTIONS, LIMITED HEA 1.2 BEADCHIP TEST KIT; HEA BEADCHIP KIT

Model Number 800-10202-08

Device Problems False Positive Result (1227); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/03/2023

Event Type  malfunction  

Event Description

Our technical support team in france received a complaint for discrepancy of results between hea 1.2 beadchip slide kit and rhce kit.There is a discordance in the rhc antigen.

Manufacturer Narrative

Update 09oct2023: the sequencing result determined that the molecular presence of cytosine at the polymorphic site c.307c and guanine at the polymorphic site c.676g are indicative of rhc(+), rhe(+) antigens1 from the rhce*01 (rhce*ce) allele, which are consistent with the serology typing and phenotypes from the rhce beadchip.The rhc(+) in sequencing is discordant with rhc(0) in hea 1.2 beadchip, which is likely due to the interfering c.150a in the rhce exon 2 primer binding region from the forward sequencing read and it is absent in the reverse sequencing read.The sequencing investigation also identifies similar interference of c.180a for c.180t in the exon 2 of the rhce gene.Presence of the unanticipated mutation in the primer region could result in the false negative call, which is listed as a limitation of the hea 1.2 beadchip package insert.

Event Description

Our technical support team in france received a complaint for discrepancy of results between hea 1.2 beadchip slide kit and rhce kit.There is a discordance in the rhc antigen.Update 09oct2023: the test report was provided to bioarray for review, and it was confirmed that the patient donor type c positive (+) with rhce/serology and c negative (-) with hea 1.2 beadchip.

• Brand Name: HEA 1.2 BEADCHIP TEST KIT
• Type of Device: HEA BEADCHIP KIT
• Manufacturer (Section D): BIOARRAY SOLUTIONS, LIMITED; 35 technology drive; suite#100; warren NJ 07059
• Manufacturer (Section G): BIOARRAY SOLUTIONS, LIMITED; 35 technology drive; suite# 100; warren NJ 07059
• Manufacturer Contact: jesdeep sidhu ; 35 technology drive; suite# 100; warren, NJ 07059 ; 9084449591
• MDR Report Key: 16846135
• MDR Text Key: 314358084
• Report Number: 3005967741-2023-00001
• Device Sequence Number: 1
• Product Code: MAO
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: 800-10202-08
• Device Catalogue Number: 800-10202-08
• Device Lot Number: 22-15-C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1