BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 7746202 · Received August 3, 2018

    Report

    Report Number
    2531779-2018-14109
    Event Type
    Malfunction
    Date Received
    August 3, 2018
    Report Date
    July 18, 2018
    Manufacturer
    ANIMAS LLC
    Product Code
    OYC
    UDI-DI
    10840406103106
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION (B)(4) 2018 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2018 WITH THE FOLLOWING FINDINGS: THE BATTERY COMPARTMENT WAS CRACKED AT THREADS ON THE SIDE. THE RETURNED BATTERY CAP WAS UNDAMAGED AND ABLE TO FIT. THE PUMP POWERED UP WITH AUDITORY AND VIBRATION TO A BLANK SCREEN. THE PUMP¿S COVER WAS REMOVED AND NO INTERMITTENT CONDITION WAS FOUND TO THE POWER PRINTED CIRCUIT BOARD. THE INVESTIGATORS WERE UNABLE TO ADEQUATELY EVALUATE THE REPORTED ¿POWER¿ COMPLAINT. HOWEVER, THE UNITY TEST CODE DOWN LOADER TOOL APPLICATION V 1.0.0 WAS USED TO UPLOAD TEST CODE V 1.0.7 TO MASTER/SLAVE/PERIPH PROCESSORS AS PER (6001112). THE UPLOAD WAS SUCCESSFUL, THE PUMP POWERED UP AND DISPLAY JUST ¿MSP¿ INSTEAD OF ¿MSP2¿. THE EEPROM WAS COMMUNICATING PROPERLY; HENCE THE DIAGNOSIS THAT THE FAILURE WAS IN THIS AREA SINCE IT WAS MISSING FROM THE DISPLAY. EEPROM FAILURE WAS CONCLUDED. OTHER TEXT : 01

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (DAMAGE) ISSUE. IT WAS REPORTED THAT THE BATTERY COMPARTMENT WAS CRACKED AND THAT THE PATIENT WAS UNABLE TO TIGHTEN THE BATTERY CAP. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE USER MAY BE UNAWARE THAT THE PUMP HAS LOST POWER, LEADING TO UNDER DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590402 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS LLC 10840406103106

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR