BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V-GO DISPOSABLE INSULIN DELIVERY DEVICE

    MDR report key: 7208040 · Received January 19, 2018

    Report

    Report Number
    1226572-2017-00010
    Event Type
    Injury
    Date Received
    January 19, 2018
    Date of Event
    June 1, 2017
    Report Date
    November 21, 2017
    Manufacturer
    VALERITAS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K103825
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: DATE CORRECTED. DATE OF REPORT: DATE CORRECTED. UDI # PROVIDED. INITIAL REPORTER CORRECTED. HEALTH PROFESSIONAL - YES CHECKED. OCCUPATION: OTHER HEALTHCARE PROFESSIONAL. TYPE OF REPORT: FOLLOW UP #1. IF FOLLOW UP, WHAT TYPE?: CORRECTION CHECKED.

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING FILED PER OUR PROCEDURE (B)(6) MEDICAL DEVICE REPORTS: PATIENT EXPERIENCED UNMANAGEABLE BLOOD GLUCOSE READINGS FROM <20-600MG/DL. EMT'S WERE CALLED TO THE PATIENT'S HOME THREE TIMES FOR LOW BG. PATIENT WAS TREATED WITH GLUCAGON INJECTION WHICH INCREASED HER BG TO 100-125 MG/DL WITHIN 30 MINUTES TO 1 HOUR. DEVICES ARE NOT AVAILABLE FOR TECHNICAL REVIEW.

    Description of Event or Problem · 1

    CDE FOR TYPE 2 DIABETIC PT. USING VGO 30 FOR 8 MONTHS, REPORTED TO VALERITAS CUSTOMER CARE (VCC) HIGH GLUCOSE 400-600 MG/DL. AE ASSESSOR SPOKE WITH PATIENT (PT.) FOR FURTHER INVESTIGATION OF CASE. PT. CONFIRMED HIGH BG AS REPORTED TO VCC. HOWEVER, PT. REPORTED TO AE ASSESSOR LOW BG THREE TIMES/EMT CALLED TO PATIENTS HOME FOR LOW BG TREATMENT WITH GLUCOMETER UNABLE TO REPORT BG READING WHICH WOULD INDICATE A BG OF 20 OR <20 MG/DL, 40 AND 50 MG/DL FOR THE THREE EMT CALLS. BECAUSE PT. COULD NOT MOVE OR TALK DURING THE LOW BG PT. WAS GIVEN A GLUCAGON INJECTION WHICH INCREASED HER BG TO 100-125 MG/DL WITHIN 30 MINUTES TO 1 HOUR. THE PT. RECOVERED WITHOUT SEQUELAE. THE VGO WAS DISCONTINUED BY HEALTH CARE PROVIDER. LIKELY CONTRIBUTING CAUSE FOR THE LOW AND HIGH BG PT. ALLEGES ARE THE VGO ALTHOUGH PT. DID NOT STATE WHAT THE VGO MALFUNCTION WAS AND PT. THREW THE VGOS OUT. THE PT. WAS LIKELY BASING HER ALLEGATIONS ON THE VGO MALFUNCTION ON HER BG LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49835 V-GO DISPOSABLE INSULIN DELIVERY DEVICE V-GO LZG VALERITAS, INC. V-GO 30 FG316217

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention