BEUDAMED
    FDA Adverse Event Other Summary report: N

    V-GO (H-PATCH) 30 UNIT BASAL/VALERITAS

    MDR report key: 1051779 · Received May 23, 2008

    Report

    Report Number
    1226572-2008-00002
    Event Type
    Other
    Date Received
    May 23, 2008
    Date of Event
    April 28, 2008
    Report Date
    May 23, 2008
    Manufacturer
    VALERITAS, LLC
    Product Code
    LZG
    PMA / PMN Number
    K050971
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT CONTINUED USING THE DEVICE IN ACCORDANCE WITH HIS PHYSICIAN'S DIRECTION AND DID NOT RETURN IT TO (B) (6). THE FACTS OF THE EVENT INDICATE THAT THE DEVICE FUNCTIONED PROPERLY AND THAT PHYSICAL EVAL OF THE DEVICE (OR RELATED DEVICES FROM THE SAME LOT) WAS NOT REQUIRED. TO PREVENT REOCCURRENCE OF LOW BLOOD GLUCOSE LEVELS, THE PHYSICIAN REDUCED THE PATIENT'S PRANDIAL INSULIN DOSE FROM 10 UNITS PER MEAL TO 6 UNITS PER MEAL. AFTER 1 WEEK, PATIENT'S INSULIN DOSE WAS FURTHER REDUCED BY CHANGING THE BASAL RATE FROM 30 UNITS/24 HOURS TO 20 UNITS/24 HOURS. THIS INTERVENTION RESULTED IN THE PATIENT'S BLOOD GLUCOSE LEVELS RETURNING TO NORMAL.

    Description of Event or Problem · 1

    (B) (6) HAS HAD INSULIN-REQUIRING TYPE 2 DIABETES FOR YEARS. PT ALSO WITH END-STAGE RENAL DISEASE WITH 3X/WEEKLY DIALYSIS. HE WAS MOST RECENTLY PRESCRIBED LANTUS 30 UNITS QHS AND HUMALOG 10 UNITS WITH EACH MEAL. PT STARTED V-GO THERAPY, WITH V-GO FILLED WITH NOVOLOG (ASPART) ON (B) (6) 2008, AND TOTAL DAILY DOSE OF INSULIN WAS MAINTAINED - BASAL RATE SELECTED WAS 30 UNITS OVER 24 HOURS; PHYSICIAN INSTRUCTED PT TO ADMINISTER 10 UNITS OF INSULIN WITH EACH MEAL. PT ADMITS TO UNPREDICTABLE MEAL SCHEDULE, LARGELY BECAUSE OF HIS DIALYSIS TREATMENTS AND REPORTS A HISTORY OF FASTING BLOOD GLUCOSE RARELY BELOW 100 MG/DL. THE MORNING OF (B) (6) 2008, WIFE FOUND PT NON-RESPONSIVE AND CALLED EMS. MEASURED BLOOD GLUCOSE BY EMS WAS 43 MG/DL. PT RESPONDED TO TREATMENT ON-SITE. ON THE EVENING OF THE (B) (6) 2008, SELF-MEASURED BLOOD GLUCOSE VIA FINGERSTICK WAS 90 MG/DL. PT TOOK JUICE AND INCREASED BLOOD GLUCOSE TO 120 MG/DL. TO PREVENT REOCCURRENCE OF LOW BLOOD GLUCOSE LEVELS, THE PHYSICIAN REDUCED THE PATIENT'S PRANDIAL INSULIN DOSE FROM 10 UNITS PER MEAL TO 6 UNITS PER MEAL. AFTER 1 WEEK, PATIENT'S INSULIN DOSE WAS FURTHER REDUCED BY CHANGING THE BASAL RATE FROM 30 UNITS/24 HOURS TO 20 UNITS/24 HOURS. THIS INTERVENTION RESULTED IN THE PATIENT'S BLOOD GLUCOSE LEVELS RETURNING TO NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V-GO (H-PATCH) 30 UNIT BASAL/VALERITAS LZG FPA DISPOSABLE INFUSION PUMP LZG VALERITAS, LLC 071117-02

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention