BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IHEALTH

    MDR report key: 14685187 · Received June 14, 2022

    Report

    Report Number
    3008573045-2022-00133
    Event Type
    Malfunction
    Date Received
    June 14, 2022
    Date of Event
    May 13, 2022
    Report Date
    June 14, 2022
    Manufacturer
    ANDON MEDICAL CO.,LTD
    Product Code
    QKP
    PMA / PMN Number
    EUA210470
    Removal / Correction Number
    MW5109731
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE IHEALTH COVID-19 ANTIGEN RAPID TEST IS AVAILABLE IN TWO PACKAGED COMPONENTS: TEST SET 1: 1 COVID-19 ANTIGEN RAPID TEST + 1 PRE FILLED TUBE + 1 SWAB. TEST SET 2: 1 COVID-19 ANTIGEN RAPID TEST +1 EMPTY TUBE AND 1 SEALED SOLUTION +1 SWAB LOT 221CO20216 USE TEST SET 1 , SO THE TUBE IS PRE FILLED , CONSISTENT WITH THE SITUATION DESCRIBED BY THE USER . THE USER MAY REFER TO TEST SET 2, SO IT IS SUSPECTED THAT THE COMPONENT IS MISSING . 2) SUSPECTED FALSE NEGATIVE INVESTIGATION: REVIEW THE RESULT OF THE LOT 221CO20216 PERFORMANCE INSPECTION REPORT IS QUALIFIED. LOT 221CO20216 RESERVED SAMPLE FOR POSITIVE TEST, THE TEST RESULT IS PASS: POSITIVE COINCIDENCE RATE 100%. BASED ON THE DETECTION PRINCIPLE AND RELEVANT CLINICAL DATA, THE TEST RESULTS OF THE IHEALTH COVID-19 ANTIGEN RAPID TEST ARE DIRECTLY RELATED TO THE VIRAL LOAD IN THE SAMPLE. FOR SAMPLES WITH LOWER VIRAL LOAD, FALSE NEGATIVES MAY OCCUR. CONTINUOUSLY COLLECT INFORMATION ON FALSE NEGATIVES OF THIS BATCH OF PRODUCTS.

    Description of Event or Problem · 0

    CUSTOMER FEEDBACK : COVID TEST KIT SUPPLIED BY (IHEALTH) DID NOT HAVE ALL THE COMPONENTS LISTED IN THE INSTRUCTIONS.THERE WAS NO SEALED SOLUTION CONTAINER. THE ITEM "EMPTY TUBE" HAD LIQUID PRE FILLED. TEST CAME BACK AS NEGATIVE EVEN THOUGH WE ARE 90% SURE IT SHOULD BE POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989966 IHEALTH COVID-19 ANTIGEN RAPID TEST QKP ANDON MEDICAL CO.,LTD ICO-3000 221CO20216

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Hospitalization