BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 9871994 · Received March 24, 2020

    Report

    Report Number
    1226572-2020-00098
    Event Type
    Malfunction
    Date Received
    March 24, 2020
    Date of Event
    March 20, 2020
    Report Date
    March 20, 2020
    Manufacturer
    VALERITAS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K103825
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) 2020 AE ASSESSOR SPOKE WITH PATIENT POA WITH PATIENT PRESENT IN THE SAME ROOM. THE PATIENT IS REPORTED TO HAVE SUFFERED SIGNIFICANT ABUSE AND THE POA STATES THE PT. "SOMETIMES HAS DIFFICULTY TAKING CARE OF HERSELF. PATIENT SOMETIMES IS VERY CHILDLIKE."

    Description of Event or Problem · 1

    THE PATIENT'S CARE TAKER / POWER OF ATTORNEY STATED SOMETIME LAST WEEK WHEN HE VISITED THE PATIENT TO TAKE HER BLOOD SUGAR HE NOTICED THE PATIENT WAS UNCONSCIOUS. THE CARE TAKER THEN TOOK HER BLOOD SUGAR AND HER BLOOD SUGAR LEVEL WAS 12. THE PATIENT'S NORMAL BLOOD SUGAR LEVEL IS 120. THE CARE TAKER STATED HE CALLED EMS AND THEY GAVE THE -PATIENT GLUCOSE TO BRING HER BLOOD SUGAR LEVEL BACK INTO A NORMAL RANGE. THE CARE TAKER STATED THE PATIENT IS UNABLE TO TAKE CARE OF HERSELF DUE TO HAVING SEVERE MENTAL ILLNESS AND POSSIBLE GAVE HERSELF MORE CLICKS THAN SHE NEEDED. THE CARE TAKER ALSO STATED THE PATIENT HAD BEEN HOSPITAL THREE TIMES IN THE PAST FEW MONTHS FOR LOW BLOOD SUGAR. THE CARE TAKER ALSO COULD NOT REMEMBER THE EXACT DATES OF THESE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338402 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG VALERITAS, INC. V-GO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention