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	09/17/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
On (b)(6) 2021, a customer reported a discrepancy on a donor sample and requested assistance.

• 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: 12965920
• Report Number: 3005967741-2021-00006
• Device Sequence Number: 14498073
• Product Code: PEP
• UDI-Device Identifier: 10888234100065
• UDI-Public: 10888234100065
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 12/09/2021
• 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