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

Model Number 800-20202-96

Device Problem False Negative Result (1225)

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

Event Date 11/17/2021

Event Type  malfunction  

Event Description

On (b)(6) 2021 the customer reported two possible discrepancies as the samples typed fya- by hea and fya+ twice by serology and hea.

Manufacturer Narrative

Bioarray's technical support specialist reviewed the customer's results and forwarded the results to bioarray's mts department for further review.The internal immucor/bioarray record for this event is pr# (b)(4).

Manufacturer Narrative

The user reported that several known u+ donor samples also resulted as u- with hea beadchip.For hea beadchip plates that had the aberrant false-negative fy(a) and u results, lower probe signal intensities were seen.For the fya/fyb probes, this resulted in the adjusted intensity ratio (delta value) falling within or around the lower gray zone region resulting in false-negative fy(a) results.The lower probe signal intensities also led to increased low signal (ls) calls on probes for the s and s antigens leading to an aberrant u- result.A product notification (correction under §806) was issued to consignees providing guidance for users to review the adjusted signal intensity ratio (delta value) on samples testing fy(a-) and to retest samples if the delta value is around or within the lower gray zone, and to repeat samples with the assigned phenotype s(ls), s(ls), u(0) to verify the results.

• 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: 12965165
• MDR Text Key: 289885979
• Report Number: 3005967741-2021-00002
• Device Sequence Number: 1
• Product Code: PEP
• UDI-Device Identifier: 10888234102618
• UDI-Public: 10888234102618
• 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,Followup
• Report Date: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 800-20202-96
• Device Catalogue Number: 800-20202-96
• Device Lot Number: 21-145-V
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2022
• 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
• Removal/Correction Number: 5967741-02/09/2022-001-C
• Patient Sequence Number: 1