BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTIMA SARS-COV-2 ASSAY

    MDR report key: 14555836 · Received May 31, 2022

    Report

    Report Number
    2024800-2022-00352
    Event Type
    Malfunction
    Date Received
    May 31, 2022
    Date of Event
    May 5, 2022
    Report Date
    May 31, 2022
    Manufacturer
    HOLOGIC INCORPORATED
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT IMPACT IS KNOWN TO DATE. A REVIEW OF THE LOGS DID NOT REVEAL ANY REAGENT OR INSTRUMENT ISSUES. TESTING OF A BLANK SAMPLE YIELDED A SARS-COV-2 POSITIVE RESULT AND, THEREFORE, CONTAMINATION MAY BE A CONTRIBUTING FACTOR TO THE ISSUE SEEN AT THE CUSTOMER SITE. ADDITIONALLY, THE CUSTOMER OBSERVED A REDUCED POSITIVITY RATE FOLLOWING A DEEP CLEANING OF THE INSTRUMENT AND WORK AREAS.

    Description of Event or Problem · 0

    FOLLOWING A CONTAMINATION INCIDENT, CUSTOMER DECIDED TO RETEST 3 SARS-COV-2 POSITIVE RESULTS FROM WL 003757-20220505-09 RAN ON THE PANTHER INSTRUMENT SN (B)(4). THE RETEST CAME BACK NEGATIVE. CUSTOMER USED ASSAY LOT 317816 FOR BOTH INITIAL TEST AND RETESTING. THE INITIAL RESULTS WERE REPORTED OUT AND LATER AMENDED. HOWEVER, THE CUSTOMER DOES NOT KNOW IF ANY TREATMENT WAS ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335395 APTIMA SARS-COV-2 ASSAY REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR HOLOGIC INCORPORATED 317816

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown