BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS VIBE

    MDR report key: 6046263 · Received October 21, 2016

    Report

    Report Number
    2531779-2016-29328
    Event Type
    Injury
    Date Received
    October 21, 2016
    Report Date
    October 16, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    OYC
    UDI-DI
    10840406100051
    PMA / PMN Number
    P130007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 2/3/2017. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/10/2017 WITH THE FOLLOWING FINDINGS: BLACK BOX SHOWS MULTIPLE CALL SERVICE 078-0008 ALARMS FOLLOWING A REPLACE BATTERY AT 5:26PM 10/16/16 INSULIN DELIVERY IS NOT RESUMED AFTER THIS TIME. DAILY INSULIN DELIVERY TOTALS PRIOR TO THIS TIME CORRECTLY REFLECT USER'S PROGRAMMED BASAL RATES. DURING REWIND PUMP GIVES A CALL SERVICE 078-0008 ALARM. MOISTURE VISIBLE IN BATTERY COMPARTMENT AND DISPLAY. BATTERY COMPARTMENT IS CRACKED ABOVE AND BELOW THE BUMPER PAD. PUMP LEAKS AT BATTERY COMPARTMENT. PUMP OPENED AND MOISTURE DAMAGE FOUND ON PCB. RECURRING ALARM DUE TO MOISTURE DAMAGE.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT THE PATIENT HAD A CS 078 ALARM ISSUE, AND THE PATIENT HAD A BLOOD GLUCOSE (BG) OVER 500 MG/DL ,WITH NAUSEA AND VOMITING. THE PATIENT DISCONTINUED PUMP THERAPY INSULIN INJECTIONS WERE GIVEN BY AN HCP. THIS COMPLAINT IS BEING REPORTED AS THE PATIENT EXPERIENCED HYPERGLYCEMIA AND THE ALARM ISSUE MAY RESULT IN A LONG TERM CESSATION OF INSULIN DELIVERY IF THE USER IS UNABLE TO RESOLVE THE ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699157 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS CORPORATION 10840406100051

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Life Threatening| R