BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS VIBE

    MDR report key: 6731379 · Received July 21, 2017

    Report

    Report Number
    2531779-2017-15542
    Event Type
    Injury
    Date Received
    July 21, 2017
    Report Date
    June 21, 2017
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    OYC
    PMA / PMN Number
    P130007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CONTRACT MANUFACTURER DEXCOM INC.(B)(4). PRODUCT NOT EXPECTED FOR RETURN (SENSORS): DEVICE RETURN IS NOT REQUIRED. .

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT THE CGM READINGS WERE INACCURATE AS COMPARED WITH THE FINGERSTICK, AND THAT AS A RESULT OF THIS HER BLOOD GLUCOSE LEVEL DROPPED TO THE LOW BG PAE OCCURRED DUE TO THE INACCURATE CGM READINGS AND NOT RECOGNIZING THAT HER BG WAS DROPPING. BG WAS 40-MG/DL WITH SEVERE DIZZINESS. PATIENT SELF TREATED WITH 3 GLUCOSE TABS. DURING TROUBLESHOOTING, CT IDENTIFIED MULTIPLE ES ERRORS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE USER REACTED TO INCORRECT CONTINUOUS GLUCOSE MONITORING DATA AND THE PATIENT HAD HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511959 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening