BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3895683 · Received June 25, 2014

    Report

    Report Number
    2531779-2014-18282
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Report Date
    June 23, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/20/2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED AND DAMAGED. THE BATTERY COMPARTMENT THREADS WERE FOUND TO BE DAMAGED. THE RETURNED BATTERY CAP WAS DAMAGED AND WAS NOT ABLE TO BE SECURED TO THE PUMP. A TEST BATTERY CAP WAS ALSO NOT ABLE TO BE SECURED TO THE PUMP. THE PUMP WAS NOT ABLE TO BE POWERED ON DUE TO THE BATTERY COMPARTMENT AND BATTERY CAP DAMAGE. THE PUMP CASE WAS REMOVED AND NO EVIDENCE OF MOISTURE OR LOOSE COMPONENTS WAS OBSERVED INSIDE THE PUMP. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE AUDIO BOLUS BUTTON COVER WAS MISSING. 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 PUMP WAS LOSING POWER INTERMITTENTLY. IT WAS NOTED THAT THAT THE BATTERY COMPARTMENT WAS CRACKED AND THE BATTERY CAP THREADS WERE STRIPPED. 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
    371227 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR