BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 4203707 · Received October 23, 2014

    Report

    Report Number
    1226572-2014-00014
    Event Type
    Injury
    Date Received
    October 23, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 7, 2014
    Manufacturer
    VALERITAS, INC
    Product Code
    KZE
    PMA / PMN Number
    K103825
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED FOLLOWING OUR PROCEDURE: PT REPORTED HYPOGLYCEMIC EVENT WITH BG READING AS LOW AS 17 WHICH REQUIRED THIRD PARTY INTERVENTION TO TREAT; DEVICE UNAVAILABLE FOR INVESTIGATION; INSUFFICIENT INFO AVAILABLE TO EXPLAIN IF V-GO CONTRIBUTED TO THE EVENT OR NOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO VALERITAS CUSTOMER CARE BY TYPE 2 DIABETIC PT THAT HE HAD EXPERIENCED HYPOGLYCEMIC EVENTS WITH THE LOWEST BLOOD GLUCOSE READING OF 17 WHILE USING THE V-GO. PT HAS BEEN USING V-GO THERAPY FOR ONE YEAR. HCP HAS CHANGED THE PT FROM V-GO 30 TO V-GO 40. PT STATED THAT THERE WERE TIMES OF LOW BG READINGS WHERE HE SELF MEDICATED BY EATING PEANUT BUTTER, MILK, AND ORANGE JUICE. PT ALSO STATED "HE HAS HAD LOW READINGS OF 17-24-25-27-33 AND HE SAID WHEN IT WAS 17 AND 24 HIS WIFE CALLED 911 AND HE CAME AWARE WHEN HE WAS IN AN AMBULANCE WITH "POLICE AROUND HIM". PT HAS ALSO STATED THAT HIS HCP IS AWARE OF THESE INCIDENTS. VALERITAS AE ASSESSORS HAVE TRIED TO CONTACT THE PT TO INVESTIGATE FURTHER, WITHOUT SUCCESS. VALERITAS PRODUCT COMPLIANCE HAS SENT A LETTER TO THE PT REQUESTING CONTACT INFO, VIA (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676667 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO KZE VALERITAS, INC V-GO 40 VG313022

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization