BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3182268 · Received June 21, 2013

    Report

    Report Number
    2531779-2013-08733
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    May 24, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS AND REPORTED AN INTERMITTENT POWER ISSUE WITH THE PUMP. THERE WAS REPORTEDLY ISSUES WITH SHORT BATTERY LIFE WITH OCCASIONAL POWER LOSS. THE REPORTER STATED THE PUMP WILL SHUT OFF AND THE PATIENT WOULD HAVE TO DISCONNECT AND RE-BOOT THE PUMP. THE PATIENT REPORTEDLY REPLACED THE BATTERY AND THE POWER ISSUE WAS NOT RESOLVED. MULTIPLE ¿REPLACE BATTERY¿ AND ¿LOW BATTERY¿ WARNINGS WERE NOTED IN PUMP HISTORY. THE BATTERY TYPE USED WAS REPORTEDLY A DURACELL ALKALINE BATTERY. THE REPORTER DENIED DAMAGE TO BATTERY COMPARTMENT BUT STATED THERE WAS CORROSION AT THE BOTTOM OF THE COMPARTMENT. THE PATIENT REPORTEDLY STOPPED USING PUMP AND WENT ON MANUAL INJECTIONS. 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
    284038 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR