BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3001350 · Received March 13, 2013

    Report

    Report Number
    2531779-2013-02641
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Report Date
    February 12, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 12/23/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/11/2013 WITH THE FOLLOWING FINDINGS:THE COMPLAINT WAS NOT DUPLICATED DURING INVESTIGATION. REVIEW OF THE PUMP¿S BLACK BOX DATA SHOWED A HISTORY OF REBOOTING EVENTS. INSPECTION OF THE PUMP¿S CASE, COMPONENTS, AND BATTERY CAP FOUND THESE TO BE WITHIN SPECIFICATION. THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT POWER ISSUES OR EMITTING ALARMS OR WARNINGS.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. 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, ALLEGING A POWER (INTERMITTENT POWER) ISSUE. THE PUMP REPORTEDLY POWERED OFF WITHOUT USER INTERVENTION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105073 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR