BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESTART COVID-19 ANTIGEN HOME TEST

    MDR report key: 20080654 · Received August 27, 2024

    Report

    Report Number
    3003966368-2024-00004
    Event Type
    Malfunction
    Date Received
    August 27, 2024
    Date of Event
    July 9, 2024
    Report Date
    July 9, 2024
    Manufacturer
    ACCESS BIO INCORPORATE
    Product Code
    QKP
    PMA / PMN Number
    EUA210314
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IN ORDER TO IDENTIFY THE TRUE ROOT CASUSE OF THIS ALLEGATION, ACCESS BIO WOULD NEED TO FURTHER COMMUNICATE WITH THE COMPLAINANT TO RULE OUT POTENTIAL ROOT CAUSES. HOWEVER, IN THE ABSENCE OF INFORMATION FROM THE CUSTOMER IT WOULD BE DIFFICULT TO RULE OUT POTENTIAL ROOT CAUSES IDENTIFIED BELOW. 1. COMPLAINANT MIGHT MISINTERPRET TEST RESULT 2. COMPLAINANT MIGHT NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU) A. INADEQUATE SAMPLE COLLECTION B. INTERPRETING RESULTS BEFORE 10 MINUTES C. NOT PERFORMING TEST IMMEDIATELY AFTER OPENING THE TEST DEVICE IN THE POUCH D. POTENTIAL CONTACT WITH FOREIGN SUBSTANCES AND HOUSEHOLD CLEANING PRODUCTS DURING SAMPLE COLLECTION AND TESTING. E. OPERATING TEST OUTSDIE OF STORAGE CONDITIONS F. EXCESSIVE BUFFER APPLICATION TO SAMPLE WELL OF TEST DEVICE 3. COMPLAINANT MIGHT NOT USE THE TEST IN ACCORDANCE WITH ITS INTENDED USE A. TAKING HIGH DOSES OF BIOTIN (>10 MG PER DAY) 4. 13% OF FALSE NEGATIVE RESULTS ARE EXPECTED BASED ON PERFROMANCE CHARACTERISTICS CLAIMED FOR THIS TEST (87% PPA) 5. TESTS MIGHT BE EXPOSED TO EXTREME ENVIRONMENTAL CONITIONS DURING STORAGE ACCESS BIO WILL CONTINUE TO MONITOR FURTHER COMPLAINTS THROUGH OUR DATA TRENDING PROGRAMS AND TAKE FURTHER ACTIONS BASED ON IDENTIFIED VALID TRENDS.

    Description of Event or Problem · 0

    CUSTOMER TESTED NEGATIVE ON BOTH TESTS IN THE KIT BOX WHEN SHE WENT TO THE DOCTOR, SHE TESTED POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1465348 CARESTART COVID-19 ANTIGEN HOME TEST COVID-19 ANTIGEN SELF-TEST QKP ACCESS BIO INCORPORATE N/A CP23A01

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Female