BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3801469 · Received May 8, 2014

    Report

    Report Number
    2531779-2014-13049
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Report Date
    April 29, 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 PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S BLACK BOX HISTORY SHOWED THAT POWER REBOOTS WERE RECORDED. THE BATTERY COMPARTMENT WAS FULLY INTACT; NO DAMAGE OR CRACKS WAS OBSERVED. THE BATTERY CAP WAS ABLE TO FULLY SECURE TO THE PUMP. THE BATTERY CAP CONTACT HEIGHT AND WIDTH MEASUREMENTS WERE FOUND TO BE WITHIN THE REQUIRED SPECIFICATIONS. THE PUMP CASE WAS REMOVED AND NO EVIDENCE OF INTERMITTENT CONDITION WAS FOUND TO THE POWER CIRCUIT. THE INTERMITTENT POWER ISSUE WAS OBSERVED IN THE PUMP¿S BLACK BOX HISTORY BUT WAS NOT ABLE TO BE FULLY INVESTIGATED DUE TO A BLANK DISPLAY SCREEN. (B)(4).

    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)(4) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT POWER) ISSUE. THE REPORTER ALLEGED THAT THE PUMP WAS LOSING POWER INTERMITTENTLY. 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
    277940 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR