BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IHEALTH

    MDR report key: 14953031 · Received July 8, 2022

    Report

    Report Number
    3008573045-2022-00176
    Event Type
    Malfunction
    Date Received
    July 8, 2022
    Date of Event
    May 20, 2022
    Report Date
    July 8, 2022
    Manufacturer
    ANDON MEDICAL CO.,LTD
    Product Code
    QKP
    UDI-DI
    00208563205894
    PMA / PMN Number
    EUA210470
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) INC., CUSTOMER SERVICE HAS FOLLOWED UP VIA EMAIL ON (B)(6)2022 TO INQUIRE FOR ADDITIONAL INFORMATION. CUSTOMER/USER REPLIED INDICATING THAT ALL FOUR POSITIVE TEST CASES CAME FROM LOT NUMBER: 211CO21215. PCR TEST AND A NEW SET OF (B)(6) TEST KITS WITH A DIFFERENT LOT NUMBER (NOT PROVIDED) WERE USED AND HAD NEGATIVE TEST RESULTS ON ALL FOUR PATIENTS/USERS. CUSTOMER/USER HAD REPORTEDLY PURCHASED THE CULPRIT (B)(6) HEALTH TEST KITS FROM DREAMHUG.COM ON (B)(6)2022, PURCHASING SIX BOXES IN TOTAL. CUSTOMER HAS REQUESTED FOR A REPLACEMENT; (B)(6) HAS GRANTED HIS REQUEST AS OF (B)(6)2022. CS HAS ALSO PRESENTED A LINK TO THE CUSTOMER/USER RELATING TO THE COUNTERFEITED OTC ANTIGEN TEST KITS. INITIAL REPORT SUGGESTED THERE WERE NO MEDICAL INTERVENTION OR TREATMENT PROVIDED; HOWEVER THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. CUSTOMER/USER WAS PROVIDED A REPLACEMENT ORDER FOR ONE (1) PACK AS A COURTESY CUSTOMER/USER MUST HAVE ACQUIRED A POTENTIAL/PROBABLE COUNTERFEITED PRODUCTS, CAUSING THE ERRONEOUS TEST RESULTS OBTAINED BY THE CUSTOMER/USER(S) ASSOCIATED WITH THIS REPORT. A SNAPSHOT OF THE ACTUAL BOX, DEPICTING THE ACTUAL LOT NUMBER HAS BEEN SHARED BY THE CUSTOMER/USER TO (B)(6) LABS, SHOWING THE LOT NUMBER NOTED ABOVE. (B)(6) LABS HAS SINCE DETERMINED LOT NUMBER: 211CO21215 TO BE COUNTERFEITED PRODUCTS, AND THEREFORE, MUST NOT BE USED. FOR EDUCATIONAL PURPOSES AND AWARENESS, THE CUSTOMER/USER WAS PROVIDED A LINK THROUGH THE FDA WEBSITE RELATING TO "COUNTERFEIT AT-HOME OTC COVID-19 DIAGNOSTIC TESTS, SEE LINK BELOW: HTTPS://WWW.FDA.GOV/MEDICAL-DEVICES/CORONAVIRUS-COVID-19-AND-MEDICAL-DEVICES/COUNTERFEIT-HOME-OTC-COVID-19-DIAGNOSTIC-TESTS. 2 TEST TO THE PRODUCTION BATCH OF PRODUCT RETENTION SAMPLES (LOT:211CO21215) , THE TEST WAS PASS.

    Description of Event or Problem · 0

    CUSTOMER FEEDBACK: PURCHASED ABOUT SIX BOXES OF (B)(6) COVID-19 ANTIGEN RAPID TEST, LOT (10) 211CO21215. WE MAY HAVE BEEN IN CONTACT WITH A COVID POSITIVE PATIENT. MY WIFE, HER SON AND WIFE AND I TESTED POSITIVE EVEN THOUGH WE WERE ASYMPTOMATIC. ALL FOUR OF US WERE IMMEDIATELY TESTED FOR PCR. THEY ARE ALL NEGATIVE. WE THEN TESTED AGAIN WITH A DIFFERENT (B)(6) RAPID TEST LOT NUMBER. THEY ARE ALL NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2086207 IHEALTH COVID-19 ANTIGEN RAPID TEST QKP ANDON MEDICAL CO.,LTD ICO-3000 211CO21215 00208563205894

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male