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

Model Number 800-20202-08

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/14/2021

Event Type  malfunction  

Event Description

On (b)(6) 2021 a customer in (b)(6) reported a potential discrepancy with hea beadchip results versus serology.

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
• Type of Device: 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
• MDR Text Key: 290070885
• Report Number: 3005967741-2021-00008
• Device Sequence Number: 1
• Product Code: PEP
• UDI-Device Identifier: 10888234100065
• UDI-Public: 10888234100065
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: BP130026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1