BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4152981 · Received October 8, 2014

    Report

    Report Number
    2531779-2014-28642
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Report Date
    September 26, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    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 MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/22/2014 WITH THE FOLLOWING FINDINGS: THE POWER COMPLAINT COULD NOT BE DUPLICATED. A REVIEW OF THE PUMP¿S BLACK BOX DATA REVEALED UNEXPLAINED PUMP REBOOTS. THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED. THERE WAS NO VISIBLE DAMAGE TO THE RETURNED BATTERY CAP, AND THE CAP WAS ABLE TO FULLY SECURE ONTO THE PUMP. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER INTERRUPTIONS OR DUPLICATED ALARMS. THE LEAK TEST FAILED DUE TO A BATTERY COMPARTMENT LEAK. THE PUMP WAS OPENED AND NO EVIDENCE OF MOISTURE OR LOOSE COMPONENTS WAS FOUND TO THE INTERNAL COMPONENTS OF THE PUMP. UNRELATED TO THE INITIAL COMPLAINT, THERE WAS EVIDENCE OF CORROSION IN THE BATTERY COMPARTMENT. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (DAMAGE) ISSUE. THE REPORTER ALLEGED THAT THE BATTERY COMPARTMENT WAS CRACKED. IT WAS REPORTED THAT THE TOP OF THE BATTERY CAP WAS WORN, AND THE CAP HAD NOT BEEN REPLACED IN FOUR TO SIX MONTHS. 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
    631486 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR