BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3192926 · Received June 27, 2013

    Report

    Report Number
    2531779-2013-09109
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    May 30, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP 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.

    Additional Manufacturer Narrative · 1

    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: REVIEW OF THE BLACK BOX DATA REVEALED ONE EVENT OF POWER ON RESET DATED (B)(6) 2013. ON EXAMINATION, THE BATTERY CAP AND THE BATTERY COMPARTMENT ARE INTACT WITHOUT DAMAGE. THE BATTERY CAP WAS ABLE TO BE SECURED TO THE PUMP PROPERLY AND MAINTAINED AN ELECTRICAL CONNECTION. ON TESTING, THE PUMP POWERED ON NORMALLY, HOWEVER, DID NOT HAVE AUDITORY ALARM FUNCTION. THE BATTERY CAP WAS LOOSENED AND THEN TIGHTENED WITHOUT LOSS OF POWER. THE PUMP WAS PRIMED AND THEN EXERCISED FOR 24 HOURS WITH NO POWER INTERRUPTION OCCURRING DURING THE EXERCISE. THE PUMP¿S COVER WAS REMOVED FOR INVESTIGATION. THE INTERNAL COMPARTMENT OF THE INSULIN PUMP REVEALED A COLD SOLDER CONNECTION ON THE AUDITORY CIRCUIT CONTACT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE DISTRIBUTER CONTACTED ANIMAS AND REPORTED NO POWER TO THE PUMP. ADDITIONAL INFORMATION WAS UNABLE TO BE OBTAINED. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED POWER ISSUE WITH THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294350 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1