BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 511258 · Received February 2, 2004

    Report

    Report Number
    MW1031030
    Event Type
    Malfunction
    Date Received
    February 2, 2004
    Date of Event
    February 2, 2004
    Report Date
    February 2, 2004
    Manufacturer
    ACTIVA
    Product Code
    KZE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT SEACHED THE INTERNET IM MAY 2003 TO LOCATE A REPLACEMENT FOR THEIR "NEEDLE FREE INSULIN INJECTOR" AND FOUND AN "ADVANTAJET" UNIT MANUFACTURED BY ACTIVA. SPECS RELATED TO THEM IN A CALL TO THEIR 800 NUMBER INDICATED THAT THE UNIT WOULD BE VERY SATISFACTORY BUT PT LEARNED THE CO WAS LOCATED IN CANADA. THEY SUPPLIED PT WITH A NUMBER FOR THEIR US REP - CAROUSEL MEDICAL, AND SUGGESTED THEY ORDER FROM THEM, AS THEY WERE MORE FAMILIAR WITH FILING US MEDICAL CLAIMS, ETC. PT ORDERED THE UNIT FROM CAROUSEL AND IT WAS SHIPPED FROM CANADA DIRECTLY TO THEM. REPORTER CREDIT CARD CHARGE WAS $100 MORE THAN THE US $495 ON THE ACTIVA WEBSITE. WHEN QUESTIONED, CAROUSEL STARTED THAT PT SHOULD HAVE USED THEIR WEBSITE RATHER THAN ACTIVA'S AND THAT THEY HAD TO CHARGE MORE TO COVER ADDITIONAL SERVICES FOR US CUSTOMERS. TO DATE, PT HAS BEEN UNABLE TO DETERMINE WHAT THESE "ADDITIONAL SERVICES" ARE. PT COMPLETED THE INSURANCE FORMS AND RETURNED THEM SEVEN MONTHS AGO. PT HAS NOT RECEIVED ANY ACCEPTANCE OR DENIAL OF CLAIM FROM MEDICARE OR SECONDARY CARRIER. WHEN QUESTIONED FOUR MONTHS AGO, CAROUSEL TOLD PT THEY WOULD CHECK INTO IT AND CALL THEM BACK TOMORROW. PT IS STILL WAITING. THE UNIT FAILED AT AGE SEVEN MONTHS - AND IT HAS A THREE-YEAR WARRANTY. PT OVERNIGHT-SHIPPED THE DEVICE BACK TO CAROUSEL FOR REPAIR. IT IS NOW FOUR WEEKS THAT PT HAS BEEN WITHOUT THE INJECTOR AND PT HAS NO IDEA OF WHEN OR IF THEY WILL EVER SEE IT AGAIN. TWO WEEKS AGO CAROUSEL TOLD PT IT WAS OUT OF THEIR CONTROL. PT FEEL'S THE SERVICE PROVIDED BY THESE PEOPLE IS COMPLETELY UNACCEPTABLE AND THE QUALITY OF THE DEVICECIS CERTAINLY QUESTIONABLE. AT THIS POINT PT IS OUT $600 AND HAS ABSOLUTELY NOTHING TO SHOW FOR IT. PT FEEL'S CAROUSEL MEDICAL SHOULD NOT BE PERMITTED TO CONDUCT BUSINESS IN THIS MANNER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA INSULIN NEEDLE - FREE INJECTOR KZE ACTIVA * *

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other