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 09/17/2021

Event Type  malfunction  

Manufacturer Narrative

On october 13, 2021, the beadmap and assay data for heak3150_1 were reviewed, and high cv and relatively high bead count for the rhe marker were observed (see "heak3150_1 beadmap").The customer was requested to provide the hea slide which received the big e positive result (heak3150) as well as the assay images for further investigation.On october 14, 2021, the assay images were reviewed and significant signal intensity variation was observed for beads from the rhe cluster with high non-specific signal.On october 15, 2021, retesting of the returned dna samples on qa retain kits from 2 different hea lots was completed.All 10 beadchips used for retest generated consistent results with "aa" genotype for the rhce-a226p probe-pair and big e negative phenotype.On october 19, 2021, the customer's slide heak3150 was received at warren under (b)(4).On october 25, 2021, the customer's slide was re-imaged using the mts ais, including re-imaging of heak3150_1 after recleaning the beadchip.The false big e positive result persisted on heak3150_1 before and after recleaning.On october 29, 2021, synthetic single target beadpools for rhe and dib were transferred to the beadchips on heak3150 and re-assayed to test for potential bead mix-up.Upon addition of the synthetic beadpools, the adjusted intensity of the rhe marker did not significantly increase.Therefore, the high non-specific signal on the rhe cluster is not due to bead mix-up from adjacent clusters.The internal immucor/bioarray record for this event is (b)(4).

Event Description

On (b)(6) 2021, a customer reported a discrepancy on a donor sample and requested assistance.

• 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: 12965920
• MDR Text Key: 284801574
• Report Number: 3005967741-2021-00006
• Device Sequence Number: 1
• Product Code: PEP
• UDI-Device Identifier: 10888234100065
• UDI-Public: 10888234100065
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BP130026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/09/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 800-20202-08
• Device Catalogue Number: 800-20202-08
• Device Lot Number: 21-2-V
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/17/2021
• Initial Date FDA Received: 12/09/2021
• 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