BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IHEALTH

    MDR report key: 16572233 · Received March 20, 2023

    Report

    Report Number
    3008573045-2023-00013
    Event Type
    Malfunction
    Date Received
    March 20, 2023
    Date of Event
    February 21, 2023
    Report Date
    March 20, 2023
    Manufacturer
    ANDON MEDICAL CO.,LTD
    Product Code
    QKP
    PMA / PMN Number
    EUA210470
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    1. NO REPORTS OF ADVERSE RELATED EVENTS WITH EITHER PATIENT OR USER (NO PATIENT DEATH, INJURY, ALLERGIC REACTION(S), OR ANY MEDICAL INTERVENTION PROVIDED). 2. LOT NUMBER: 221CO20124 HAS NOT BEEN IDENTIFIED BY IHEALTH LABS, INC., AS A COUNTERFEIT PRODUCT, SO IT IS SAFE TO CONCLUDE THAT THE DEVICE/KIT RECEIVED IS A VALID IHEALTH LABS, INC., MANUFACTURED TEST KIT PRODUCT. 3. INITIAL REPORTS SUGGESTED THAT THE IHEALTH ANTIGEN TEST KIT WAS NOT TAMPERED WITH, ALTERED, OR COMPROMISED, AS NO EVIDENCE THAT THE USER/PATIENT HAD SEEN EVIDENCE OF PRODUCT ALTERATION. 4. A FALSE NEGATIVE RESULT MAY OCCUR IF THE TEST RESULT IS READ BEFORE 15 MINUTES OR AFTER 30 MINUTES. THERE WAS NO INDICATION TO CONFIRM OR DENY IF THE USER/PATIENT HAD UTILIZED THE TEST KIT APPROPRIATELY AS PER INTENDED USE OR OFF USE. 5. TEST TO THE PRODUCTION BATCH OF PRODUCT RETENTION SAMPLES (LOT: 221CO20124 ) , THE TEST WAS PASS.

    Description of Event or Problem · 0

    THE USER WAS NOTED TO HAVE REPORTED VIA VOICEMAIL, AS FOLLOWS: "I HAD A FALSE NEGATIVE FOR, AN I HEALTH LOT NUMBER: 2, 2, ONE C O 20124 G T I N. 2085636205894 TESTED NEGATIVE ON SUNDAY, THE NINETEENTH OF FEBRUARY, AND I WAS POSITIVE AT THE DOCTOR'S OFFICE, WHERE THEY ANTIGEN TEST WITH FLU POC AT THE DOCTOR'S OFFICE. MY PHONE NUMBER IS (B)(6), WITH ANY QUESTIONS THE C. DID SHOW, SO THE CONTROL WAS FINE. THANK YOU."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1713873 IHEALTH COVID-19 ANTIGEN RAPID TEST QKP ANDON MEDICAL CO.,LTD ICO-3000 221CO20124

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Unknown