BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS VIBE

    MDR report key: 6224312 · Received January 4, 2017

    Report

    Report Number
    2531779-2017-00250
    Event Type
    Injury
    Date Received
    January 4, 2017
    Date of Event
    December 8, 2016
    Report Date
    December 8, 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
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 02/16/2017. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/31/2017 WITH THE FOLLOWING FINDINGS: REVIEW OF THE BLACK BOX DATA REVEALED UNEXPLAINED POWER ON RESET EVENTS OBSERVED ON (B)(6) 2016. POWER ON RESET EVENTS WERE ALSO OBSERVED AFTER REPLACE BATTERY ALARMS AND CS-078-0008 ALARM ON (B)(6) 2016 BEGINNING AT 21:51; DELIVERIES WERE NEVER RESUMED. REVIEW OF THE TOTAL DAILY DOSES ADDED UP CORRECTLY. A BATTERY CAP WAS NOT RETURNED; A NEW TEST BATTERY CAP WAS ABLE TO ATTACH TO THE PUMP. ON INVESTIGATION, THE PUMP POWERED ON TO THE VERIFY SCREEN WITH AUDIBLE & VIBRATORY FEATURES. THE PUMP WAS NOT ABLE TO BE EXERCISED DUE TO AN UNRELATED ISSUE THAT HAS BEEN REPORTED ON MEDWATCH REPORT 2531779-2016-35082. THE BATTERY COMPARTMENT WAS CRACKED ABOVE AND BELOW THE BUMPER PAD WITH CORROSION OBSERVED INSIDE BATTERY COMPARTMENT AS WELL AS BEHIND THE DISPLAY SCREEN. LEAK TESTING FAILED DUE TO A BATTERY COMPARTMENT LEAK. MOISTURE WAS ALSO FOUND INSIDE THE PUMP ON THE PRINTED CIRCUIT BOARD AND ON THE INTERNAL COMPONENTS. INVESTIGATION CONFIRMED THE ALLEGATION OF MOISTURE INGRESS BUT DID NOT DUPLICATE THE ALLEGED POWER ISSUE.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS ALLEGING THE PATIENT¿S BLOOD GLUCOSE ON (B)(6) 2016 WAS 353 MG/DL WITH BLURRED VISION, EXCESS URINATION, EXTREME THIRST, NAUSEA, AND SYMPTOMS OF DEHYDRATION. IT WAS REPORTED THE BATTERY COMPARTMENT WAS CRACKED AND THE BATTERY CAP WAS OVER 13 MONTHS OLD. A POWER LOSS ISSUE WAS REPORTED. THE REPORTER NOTED THE PATIENT DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT, THEY REMAINED ON PUMP THERAPY, AND THE PUMPS SETTINGS WERE NOT RECENTLY CHANGED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED HEALTH EVENT WAS ATTRIBUTED TO AN ALLEGED PUMP MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5641 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS CORPORATION 10840406100051

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Life Threatening