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

Model Number	800-20202-08
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021 a customer in (b)(6) reported a potential discrepancy with hea beadchip results versus serology.
Additional Manufacturer Narrative
When initially reported, insufficient information was provided to determine if a device malfunction occurred.By november 24, 2021 no additional information was provided by the customer but (at this time) internal bioarray review determined (with an abundance of caution) that the potential cause of the event could be assigned to the possibility of a device malfunction.No definitive cause for the event has been determined.The internal immucor/bioarray record for this event is pr# (b)(4).

• Brand Name: PRECISETYPE HEA MOLECULAR BEADCHIP TEST
• Common Device Name: MOLECULIAR ERYTHROCYTE TYPING TEST
• Manufacturer (Section D): BIOARRAY SOLUTIONS; 35 technology drive, suite 100; warren NJ 07059
• Manufacturer (Section G): BIOARRAY SOLUTIONS; 35 technology drive, suite 100; warren NJ 07059
• Manufacturer Contact: howard yorek ; 35 technology drive, suite 100; warren, NJ 07059 ; 6784184738
• MDR Report Key: 13081704
• Report Number: 3005967741-2021-00008
• Device Sequence Number: 4517424
• Product Code: PEP
• UDI-Device Identifier: 10888234100065
• UDI-Public: 10888234100065
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: BP130026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/23/2021

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: 10/30/2022
• Device Model Number: 800-20202-08
• Device Catalogue Number: 800-20202-08
• Device Lot Number: 21-105-V
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 12/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown