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

Model Number	800-20202-96
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported two run failures.Low signal (ls) and indetermined call (ic) warnings.
Additional Manufacturer Narrative
Multiple low signal (ls) and indetermined call (ic) warnings due to chip to chip variation with location specific weak signal.
Event or Problem Description
(b)(6) reported that during their in-coming quality testing there were two run failures due to invalid controls as well as multiple sample failures during these run failures.The invalid ref-pa and/or ref-pb as well as multiple sample failure results were observed across three plate ids heam4137 heam4138 and heam4154 while testing with the hea assay lot# 22-99-v.The customer in-coming quality testing failed for hea plate lot# 22-99-v due to high frequency of invalid samples.Bioarray completed in-house testing of the customer's returned pcr product with our qa retain kit heam4143 for hea lot# 22-99-v.The plate exhibited poor performance and bioarray replicated the invalid positive controls as well as the multiple sample failures.The no type determined (ntd) chips are due to weak assay signal on the three alleged plates and on one of the investigation plates.There were high signal intensity probes and weak probes on the ntd chips, which suggest the weak signal is not due to surface blockage, inhibition of emap reaction, and probe inactivation.Weak assay signal is unrelated to bsa coating on the beads.Assay signal from the weak signal probes could not be fully recovered in the re-assay, which suggest the weak signal is due to loss of the probes on the bead surface.The hea lot# 22-99-v was recalled.The customer notification was communicated to community blood centre-kansas city on the decision and disposition of the recall lot.

• Brand Name: PRECISETYPE HEA MOLECULAR BEADCHIP 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, 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: 16080734
• Report Number: 3005967741-2022-00004
• Device Sequence Number: 14992368
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2023

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: 22-99-V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2022
• Supplement Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 12/30/2022
• Supplement Report FDA Received Date: 04/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3005967741-001
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown