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

Model Number	800-20202-96
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2021
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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).
Additional 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
• 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: 12965165
• Report Number: 3005967741-2021-00002
• Device Sequence Number: 14565834
• Product Code: PEP
• UDI-Device Identifier: 10888234102618
• UDI-Public: 10888234102618
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Followup
• Report Date (Section B): 02/22/2022

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2021
• Supplement Date Received by Manufacturer: 02/08/2022
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 02/22/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 5967741-02/09/2022-001-C
• Patient Sequence Number: 1
• Patient Sex: Unknown