BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2050593 · Received March 15, 2011

    Report

    Report Number
    2531779-2011-01606
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Report Date
    February 14, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    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 DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORTER REPORTED THE PUMP WOULD NOT POWER ON, GAVE NO AUDIBLE PROMPTS OR VISUAL DISPLAY AND NO VIBRATIONS. THE PATIENT NOTED THE PUMP WAS EXPOSED TO A COMMERCIAL MAGNET FROM CLOTHING. THE PATIENT REPLACED THE LITHIUM BATTERY TO NO AVAIL, AND THE PUMP DID NOT POWER ON. TROUBLESHOOTING REVEALED THE BATTERY CAP WAS SECURE, THERE WAS NO CORROSION OR CRACKS IN THE BATTERY COMPARTMENT, THE PUMP WAS NOT EXPOSED TO WATER AND HAD NOT SUFFERED ANY TRAUMA. THE PATIENT HAD NOT EXPERIENCED ANY SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVELS AND REPORTED NO ADVERSE EVENT OCCURRED DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM LZG ANIMAS CORP. ONE TOUCH PING NA

    Patients

    Seq Age Sex Outcome Treatment
    1