MAUDE Adverse Event Report: BIOARRAY SOLUTIONS, LIMITED PRECISETYPE HEA MOLECULAR BEADCHIP KIT; PRECISETYPE HEA BEADCHIP KIT

Model Number	800-20202-08
Medical Device Problem Codes	False Negative Result (1225); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Customer inquired about an indetermined call ( ic) on a run.Upon review, ic is on v antigen.Customer repeated the sample and got a negative result for v antigen.They did further investigation and determined the sample had been previously tested in (b)(6) 2021, which had a positive result for v antigen.Only known patient history is sickle cell (scd), no history of transplant.
Event or Problem Description
Customer inquired about an indetermined call ( ic) on a run.Upon review, ic is on v antigen.Customer repeated the sample and got a negative result for v antigen.They did further investigation and determined the sample had been previously tested in (b)(6) 2021, which had a positive result for v antigen.Only known patient history is sickle cell (scd), no history of transplant.
Event or Problem Description
Customer inquired about an indetermined call ( ic) on a run.Upon review, ic is on v antigen.Customer repeated the sample and got a negative result for v antigen.They did further investigation and determined the sample had been previously tested in (b)(6) 2021, which had a positive result for v antigen.Only known patient history is sickle cell (scd), no history of transplant.
Additional Manufacturer Narrative
On 09nov2023, updated mdr with follow-up 002 addressing the additional information from the fda for missing results of the investigation.The requested investigation findings, conclusion and health impact assesment have been updated accordingly.

• Brand Name: PRECISETYPE HEA MOLECULAR BEADCHIP KIT
• Common Device Name: PRECISETYPE 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: 16956398
• Report Number: 3005967741-2023-00002
• Device Sequence Number: 6850753
• Product Code: PEP
• UDI-Device Identifier: 10888234100065
• UDI-Public: 10888234100065
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/09/2023

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: 800-20202-08
• Device Catalogue Number: 800-20202-08
• Device Lot Number: 22-118-V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/21/2023
• Supplement Date Received by Manufacturer: 04/21/2023; 04/21/2023
• Initial Report FDA Received Date: 05/18/2023
• Supplement Report FDA Received Date: 10/12/2023; 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2022
• 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