MAUDE Adverse Event Report: BIOARRAY SOLUTIONS LTD PRECISETYPE HEA BEADCHIP PLATE

Model Number	800-20202-96
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The precisetype hea lot#: 22-157-v problem issue could be tested or reproduce because the dna sample is not available.A review of batch record was conducted and we found no additional issues.In 2022, bioarray did observe some manufactured bead library have differences in the fya probe intensity and the fya/fyb intensity ratio.The variation in the intensity could contribute to the assay variation.In 2002, we reviewed the certificate of analyses for the fya/fyb oligonucleotide probes.We reviewed the accuracy specification by comparing the calculated molecular weight of the oligonucleotide.The molecular weight was determined using the electrospray ionization (esi) technique in mass spectrometry to be ±1%.The purity specification is >80% by area comparison in capillary electrophoresis (ce) or hplc peaks.The accuracy and purity of the fya/fyb oligonucleotide probes meet our specifications.Unfortunately, due to unavailability of the dna sample, we could not perform any additional testing or investigation.We also could not confirm if there is any polymorphism associated with this donor sample.In addition, the health hazard or risk associated with this issue is considered low since there is no risk to the donor.Any recipient will be typed and cross matched to the donor.
Event or Problem Description
Customer reported typing discrepancy on a sample for fya with precisetype hea plate using lot#: 22-157-v typed fy(a-) but serology on a subsequent donation was fy(a+).Customer re-ran the original dna donor sample on a slide (heaq6165_8) with precisetype hea slide using lot#: 24-186-v and obtained fy(a+), matching serology.All other antigens matched the original run.
Additional Manufacturer Narrative
The precisetype hea lot# 22-157-v problem issue could not be tested or reproduce because the dna sample is not available.A review of batch record was conducted and we found no additional issues.In 2022, bioarray did observe some manufactured bead library have differences in the fya probe intensity and the fya/fyb intensity ratio.The variation in the intensity could contribute to the assay variation.In 2002, we reviewed the certificate of analyses for the fya/fyb oligonucleotide probes.We reviewed the accuracy specification by comparing the calculated molecular weight of the oligonucleotide.The molecular weight was determined using the electrospray ionization (esi) technique in mass spectrometry to be ±1%.The purity specification is >80% by area comparison in capillary electrophoresis (ce) or hplc peaks.The accuracy and purity of the fya/fyb oligonucleotide probes meet our specifications.Unfortunately, due to unavailability of the dna sample, we could not perform any additional testing or investigation.We also could not confirm if there is any polymorphism associated with this donor sample.In addition, the health hazard or risk associated with this issue is considered low since there is no risk to the donor.Any recipient will be typed and cross matched to the donor.Additional information as of july 16 2025 the complaint device or kit was not available for further investigation.In the root cause investigation, bioarray did review the adusted intensity data by comparing the complaint chips using the precisetype hea beadchip plate lot (lot#22-157-v) and the retest chips using the precisetype hea beadchip slide lot (lot# 24-186-v).
Event or Problem Description
Customer reported typing discrepancy on a sample for fya with precisetype hea plate using lot#22-157-v typed fy(a-) but, serology on a subsequent donation was fy(a+).Customer re-ran the original dna donor sample on a slide (heaq6165_8) with precisetype hea slide using lot#24-186-v and obtained fy(a+), matching serology.All other antigens matched the original run.

• Brand Name: PRECISETYPE HEA BEADCHIP PLATE
• Common Device Name: PRECISETYPE HEA BEADCHIP
• Manufacturer (Section D): BIOARRAY SOLUTIONS LTD; 35 technology drive; suite 100; warren NJ 07059
• Manufacturer (Section G): BIOARRAY SOLUTIONS LTD; 35 technology drive; suite 100; warren NJ 07059
• Manufacturer Contact: jesdeep sidhu ; 35 technology drive; suite 100; warren, NJ 07059
• MDR Report Key: 21905301
• Report Number: 3005967741-2025-00003
• Device Sequence Number: 4085026
• Product Code: PEP
• UDI-Device Identifier: 10888234102618
• UDI-Public: 10888234102618
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: BP130026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

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: 02/29/2024
• Device Model Number: 800-20202-96
• Device Catalogue Number: 800-20202-96
• Device Lot Number: 22-157-V
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2025
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown