BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTIMA SARS-COV-2 ASSAY

    MDR report key: 13050185 · Received December 21, 2021

    Report

    Report Number
    2024800-2021-00015
    Event Type
    Malfunction
    Date Received
    December 21, 2021
    Date of Event
    September 16, 2021
    Report Date
    December 20, 2021
    Manufacturer
    HOLOGIC INCORPORATED
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HOLOGIC TECHNICAL SUPPORT (TS) REVIEWED THE LOGS AND DETERMINED NO HARDWARE OR REAGENT PREPARATION ISSUES. ALL VALUES ARE WITHIN RANGE. TS RECOMMENDED FOR THE CUSTOMER TO REVIEW THEIR EXTERNAL QUALITY CONTROL (EQC) STORAGE AND HANDLING. NO FURTHER ISSUES WERE REPORTED.

    Additional Manufacturer Narrative · 0

    HOLOGIC TECHNICAL SUPPORT (TS) REVIEWED THE LOGS AND DETERMINED NO HARDWARE OR REAGENT PREPARATION ISSUES. ALL VALUES ARE WITHIN RANGE. TS RECOMMENDED FOR THE CUSTOMER TO REVIEW THEIR EXTERNAL QUALITY CONTROL (EQC) STORAGE AND HANDLING. NO FURTHER ISSUES WERE REPORTED.

    Description of Event or Problem · 0

    CUSTOMER CALLED HOLOGIC TECHNICAL SUPPORT (TS) REQUESTING FOR THEIR LOGS (WORKLIST 001374-20210907-12) TO BE REVIEWED AND FOR HOLOGIC TO PROVIDE FEEDBACK ON POSSIBLE CAUSE OF LOWER RLU VALUES. CUSTOMER USED SARSCOV2 ASSAY LOT 294803 ON PANTHER INSTRUMENT SERIAL (B)(4). CUSTOMER NOTED THAT THE VALUES FOR POSITIVE RESULTS WERE RUNNING LOWER THAN USUAL. CONTROLS ARE VALID BUT OTHER VALUES ARE LOWER THAN EXPECTED.

    Description of Event or Problem · 0

    CUSTOMER CALLED HOLOGIC TECHNICAL SUPPORT (TS) REQUESTING FOR THEIR LOGS (WORKLIST 001374-20210907-12) TO BE REVIEWED AND FOR HOLOGIC TO PROVIDE FEEDBACK ON POSSIBLE CAUSE OF LOWER RLU VALUES. CUSTOMER USED SARSCOV2 ASSAY LOT 294803 ON PANTHER INSTRUMENT SERIAL (B)(4). CUSTOMER NOTED THAT THE VALUES FOR POSITIVE RESULTS WERE RUNNING LOWER THAN USUAL. CONTROLS ARE VALID BUT OTHER VALUES ARE LOWER THAN EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1953275 APTIMA SARS-COV-2 ASSAY REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR HOLOGIC INCORPORATED 294803

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown