BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTIMA SARS-COV-2/FLU MULTIPLEX ASSAY

    MDR report key: 13083405 · Received December 24, 2021

    Report

    Report Number
    2024800-2021-00079
    Event Type
    Malfunction
    Date Received
    December 24, 2021
    Date of Event
    November 15, 2021
    Report Date
    December 24, 2021
    Manufacturer
    HOLOGIC INCORPORATED
    Product Code
    QLT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HOLOGIC PRODUCT APPLICATION SPECIALIST (PAS) REVIEW OF THE LOGS AND DID NOT FIND ANY REAGENT PREPARATION ISSUES OR HARDWARE ISSUES. OF NOTE, SAMPLE RESULT PRODUCED RLU'S BETWEEN 565K - 738K, WHICH IS LOWER THAN WHAT IS TYPICALLY SEEN IN POSITIVE SAMPLES. THUS, PER PAS ANALYSIS, THE SAMPLE MAY BE LOW TARGET SAMPLE, WHICH MAY NOT REPEAT UPON RETESTING, OR THE SAMPLES MAY POSSIBLY BE CONTAMINATED. NO PRODUCT IMPACT IS KNOWN TO DATE.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT THEY OBTAINED INCORRECT RESULTS FOR THIRD PARTY EXTERNAL QUALITY CONTROL SAMPLES (EQCS) DURING APTIMA SARS-COV-2/FLU ASSAY VALIDATION ON THE PANTHER INSTRUMENT SN (B)(4) . IN ADDITION, THE CUSTOMER NOTED THAT A SAMPLE FROM WORKLIST 003070-20211119-23 THAT PREVIOUSLY PRODUCED POSITIVE RESULT USING THE APTIMA SARS-COV-2 ASSAY LOT 307201, PRODUCED NEGATIVE SARS-COV-2 RESULT DURING APTIMA SARS-COV-2/FLU ASSAY VALIDATION USING LOT 303906.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1981922 APTIMA SARS-COV-2/FLU MULTIPLEX ASSAY COVID-19 MULTI-ANALYTE RESPIRATORY PANEL NUCLEIC ACID DEVICES QLT HOLOGIC INCORPORATED 303906

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown