BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 3122471 · Received May 20, 2013

    Report

    Report Number
    1226572-2013-00002
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 20, 2013
    Manufacturer
    VALERITAS, INC
    Product Code
    LZG
    PMA / PMN Number
    K103825
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTED THREE TIMES TO REACH THE PT ON THE # PROVIDED AND THERE IS NO ONE RESIDING AT THE RESIDENCE BY THE PT NAME OR USING A V-GO DEVICE. UNABLE TO INVESTIGATE THIS CASE WITHOUT SPEAKING TO THE PT. IT APPEARS THE PT WAS HOSPITALIZED AND HAD HYPERGLYCEMIA AND A HEART CATHETERIZATION. IT IS UNCLEAR IF THIS WAS ONE OR TWO EVENTS. THE INITIAL CALL TO THE VALERITAS CALL CENTER ALSO NOTED THAT WHEN THE PT WAS RELEASED FROM THE HOSP THE PT BG WAS 700 (HYPERGLYCEMIC), BUT IT IS NOT CLEAR IF THE PT WAS ON THE V-GO WHEN SHE WAS RELEASED FROM THE HOSP. UNABLE TO DETERMINE CONTRIBUTORY CAUSES TO THE HYPERGLYCEMIA AND PT'S PRE-V-GO 30 BG RANGES. THE DEVICE WAS NOT ABLE TO BE RECOVERED FOR INVESTIGATION. IT WOULD NOT BE EXPECTED TO HAVE A HIGHER RISK OF HYPERGLYCEMIA GOING FROM THE V-GO 20 (20 UNITS/DAY BASAL DELIVERY OF INSULIN) TO THE V-GO 30 (30 UNITS/DAY BASAL DELIVERY OF INSULIN). THE CALLER DID STATE THAT THE PT WAS BACK ON INJECTION THERAPY WITH NOVOLOG.

    Description of Event or Problem · 1

    IT WAS REPORTED TO VALERITAS CUSTOMER CARE BY PT'S HUSBAND THAT, WHILE WAITING FOR PRIOR AUTHORIZATION, THE PT'S DIABETES CENTER RAN OUT OF V-GO 20S AND SWITCHED THE PT TO THE V-GO 30. HER BLOOD SUGAR, REPORTEDLY WENT OUT OF CONTROL WHILE ON THE V-GO 30 AND SHE EVENTUALLY HAD TO GO TO THE HOSP FOR HYPERGLYCEMIA. REPORTER STATED THAT EVEN WHEN SHE GOT OUT OF THE HOSP, HER BLOOD SUGAR WAS 700. HE ALSO SAID THAT THE DOCTOR DID MENTION KETONES AT THE HOSP. PT WAS TAKEN TO THE HOSP AFTER SHE AND THE REPORTER THOUGHT THAT SHE HAD A HEART ATTACK. THEY WERE WALKING UPTOWN WHEN THE PT SEEMED LIKE SHE WAS HAVING A HEART ATTACK. REPORTER WENT ON TO STATE THAT AT THE HOSP, THEY DID PUT IN A HEART CATHETER. THIS HAPPENED ABOUT 2-3 DAYS AGO. PT IS AT HOME NOW USING HER PREVIOUS INSULIN THERAPY, WHICH CONSISTS OF A SYRINGE WITH NOVOLOG. PT IS A TYPE 1 DIABETIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222542 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG VALERITAS, INC V-GO 30 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization