BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3912202 · Received July 3, 2014

    Report

    Report Number
    2531779-2014-19037
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Report Date
    June 29, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 (B)(4) 2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP BLACK BOX DATA REVEALED NO RELATED EVIDENCE OF AN INTERMITTENT POWER ISSUE. THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED. THE RETURNED BATTERY CAP THREADS WERE DAMAGED AND THE CAP WAS UNABLE TO PROPERLY SECURE TO THE PUMP; A POWER ISSUE WAS NOT OBSERVED. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER INTERRUPTIONS OR DUPLICATED ALARMS. THE PUMP WAS OPENED AND REMOVED FROM THE CASE AND NO EVIDENCE OF MOISTURE OR LOOSE COMPONENTS WERE OBSERVED INSIDE THE PUMP. UNRELATED TO THE INITIAL COMPLAINT, THE AUDIO BOLUS BUTTON WAS UNRESPONSIVE. THE AUDIO BOLUS BUTTON COVER WAS MISSING THE WHITE SLUG COMPONENT. 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. REPORTEDLY, THE PUMP HAD INTERMITTENT POWER ISSUE. IT WAS REPORTED THAT THE BATTERY COMPARTMENT WAS CRACKED AND THE CAP WAS UNABLE TO TIGHTEN PROPERLY ON TO THE PUMP. THE REPORTER NOTED THAT THE BATTERY CAP WAS UNDAMAGED AND THERE WAS NO MOISTURE OR CORROSION IN THE PUMP. 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
    390935 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR