BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3130012 · Received May 24, 2013

    Report

    Report Number
    2531779-2013-07049
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Report Date
    May 1, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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

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

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 ALLEGING THE KEYPAD BUTTONS ON THE PUMP WERE STICKING. NO FURTHER INFORMATION WAS AVAILABLE. ANIMAS CUSTOMER TECHNICAL SUPPORT MADE SEVERAL ATTEMPTS TO CONTACT THE REPORTER TO FOLLOW UP ON THE COMPLAINT; HOWEVER, THE REPORTER DID NOT RESPOND. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED KEYPAD MALFUNCTION REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231202 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR