BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MESA BIOTECH ACCULA

    MDR report key: 10800575 · Received November 5, 2020

    Report

    Report Number
    MW5097675
    Event Type
    Malfunction
    Date Received
    November 5, 2020
    Report Date
    November 4, 2020
    Manufacturer
    MESA BIOTECH, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE (B)(6) OBTAINED 10 MESA ACCULA DEVICES FOR RAPID PCR TESTING OF COVID -19 TARGETING SARS-COV-2. INTENDED USE WAS TO PROVIDE RAPID TESTING IN PREADMISSION PATIENT (PAT) POPULATION TO SUPPORT SAME DAY CHANGES TO THE SURGICAL SCHEDULE. ON (B)(6) 2020 THE 3 DEVICES USED FOR PAT TESTING WERE OBSERVED TO HAVE PLASTIC FALLING OUT OF THE DEVICE. THE VENDOR WAS CONTACTED ON OCT 27, 2020 TO REPORT DEVICE FAILURE. VENDOR INDICATED THEY HAD RECEIVED PRIOR REPORTS OF INVALID TESTS BUT NO PRIOR REPORTS ON THE PHYSICAL DEVICE FAILURE. RISK MANAGEMENT WAS NOT CONTACTED SINCE NO DIRECT PATIENT TESTING PERFORMED, THIS WAS ONLY VALIDATION STUDY. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1254994 MESA BIOTECH ACCULA REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR MESA BIOTECH, INC. 30032
    1254995 MESA BIOTECH ACCULA REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR MESA BIOTECH, INC. 30032
    1254996 MESA BIOTECH ACCULA REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR MESA BIOTECH, INC 30032

    Patients

    Seq Age Sex Outcome Treatment
    1