BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESTART COVID-19 ANTIGEN TEST

    MDR report key: 20250905 · Received September 18, 2024

    Report

    Report Number
    3003966368-2024-00005
    Event Type
    Malfunction
    Date Received
    September 18, 2024
    Date of Event
    February 1, 2024
    Report Date
    March 8, 2024
    Manufacturer
    ACCESS BIO INCORPORATE
    Product Code
    QKP
    PMA / PMN Number
    EUA202625
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS ONGOING FOR THE CASE. 09/04/2024 (DELAYED FOLLOW UP REPORT, OVERSIGHT) COMPLAINT WAS CLOSED ON 03/11/2024) THIS COMPLAINT IS CLOSED, AS THE QC PERSONNEL MADE THREE ATTEMPTS TO COLLECT ADDITIONAL INFORMATION IN GOOD FAITH. THIS IS ADDITIONAL INFORMATION FOR MDR_POC_032 (MDR SUBMISSION # 3003966368-2024-00001)

    Description of Event or Problem · 0

    HEALTH LABORATORIES SERVICES, INC REPORTED AS ONE OF THE MEDICAL TECHNOLOGIST RAN THE CONTROLS FOR THE LOT MENTIONED AND SHE FOULD OUT THAT THE NEGATIVE CONTROL WAS PAINTED AT THE TEST AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1809359 CARESTART COVID-19 ANTIGEN TEST COVID-19 ANTIGEN TEST QKP ACCESS BIO INCORPORATE CH23F01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown