BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4100744 · Received September 19, 2014

    Report

    Report Number
    2531779-2014-26771
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Report Date
    September 7, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION (B)(4) 2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE COMPLAINT COULD NOT BE DUPLICATED OR CONFIRMED. A REVIEW OF THE PUMP¿S CURRENT BLACK BOX DATA REVEALED NO PUMP REBOOTS. DATA FROM THE DATE OF THE COMPLAINT HAD BEEN OVERWRITTEN DUE TO CONTINUED PUMP USE. THERE WAS NO VISIBLE DAMAGE OBSERVED TO THE BATTERY COMPARTMENT. THE BATTERY CAP WAS ABLE TO FULLY SECURE ONTO THE PUMP, AND THE BATTERY CAP CONTACT MEASURED WITHIN SPECIFICATIONS. THE PUMP POWERED ON WITH THE RETURNED BATTERY CAP, AND WAS EXERCISED FOR 24 HOURS WITH NO POWER INTERRUPTIONS OR DUPLICATED ALARMS. THE PUMP WAS OPENED AND NO EVIDENCE OF MOISTURE OR LOOSE COMPONENTS WAS FOUND INSIDE THE PUMP. 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.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT POWER) ISSUE. 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
    581873 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR