BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCULA SARS-COV-2 TEST

    MDR report key: 11732360 · Received April 27, 2021

    Report

    Report Number
    11732360
    Event Type
    Malfunction
    Date Received
    April 27, 2021
    Date of Event
    April 21, 2021
    Report Date
    April 23, 2021
    Manufacturer
    MESA BIOTECH, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SOME OF THE ACCURA SUPPLIED PIPETTES ARE SHORTER AND THEY DO NOT WORK WITH THE TEST CARTRIDGES. THIS CAUSES A DELAY IN PATIENT RESULTS, AS WELL AS A WASTE OF THE TEST CARTRIDGES. THE LENGTH OF THE SHORT SAMPLE POSSIBLY CAUSES THE ERROR CODE "INADEQUATE SAMPLE" ON THE DOCK. THIS IS CAUSING A DELAY IN PATIENT COVID-19 TESTING RESULTS BEING OBTAINED, WHICH COULD DELAY TREATMENT. THIS ISSUE WAS RECENTLY IDENTIFIED AT OUR OTHER HEALTH SYSTEM SITES. WE THEN CHECKED AND IDENTIFIED THIS PIPETTE ISSUE IN 22 OF OUR KITS AT THE HOSPITAL WITH LOT # AND EXPIRATION DATE PROVIDED IN THIS REPORT. NOTE: THE DATE ABOVE IS OF ONE OF THE INSTANCES FROM ANOTHER SITE THAT TRIGGERED THE REVIEW OF THE KITS. WE WILL PROVIDE ADDITIONAL LOT # AND SITE INFORMATION IN A FOLLOW-UP MESSAGE TO THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629300 ACCULA SARS-COV-2 TEST REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR MESA BIOTECH, INC. COV4100 V2103F681K

    Patients

    Seq Age Sex Outcome Treatment
    1 1095 DA