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

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	10/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer reported a possible discrepancy as a sample typed fya- and upon retest, the same sample resulted in fya+.Update 01aug2023: the nature of the health hazard is considered medium since multiple false-negative results have been confirmed.The risk could be mitigated if the customer is aware of the discrepant results and can rerun the samples on another carrier.In addition, these flipped calls occurred on donor samples, and there is no risk to the donor.Any recipient would be typed and cross-matched to the donor.
Event or Problem Description
Multiple false negative calls on fya.Possible discrepancy as a sample typed fya- and upon retest, the same sample resulted in fya+.Update as of 01aug2023: trending analysis determined this is the only complaint for this lot 22-117-v of this complaint nature, however the second instance of the customer reporting false fya(0) results within the past year.The false fya(0) results are caused by the significant change in the fya/fyb delta values for samples that should result as fya(+) and is due to the reduced reactivity of the fya beads relative to the fyb beads of the beadchips.The underlying root cause of the reduced reactivity is unknown at this time.

• Brand Name: PRECISETYPE HEA MOLECULAR BEADCHIP TEST KIT
• Common Device Name: MOLECULIAR ERYTHROCYTE TYPING TEST
• Manufacturer (Section D): BIOARRAY SOLUTIONS, LIMITED; 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 ; 9084449591
• MDR Report Key: 17435683
• Report Number: 3005967741-2022-00003
• Device Sequence Number: 8978526
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/01/2023

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: 12/31/2023
• Device Model Number: 800-20202-96
• Device Catalogue Number: 800-20202-96
• Device Lot Number: 22-117-V
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2022
• Initial Report FDA Received Date: 08/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2022
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown