BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4113793 · Received September 24, 2014

    Report

    Report Number
    2531779-2014-27297
    Event Type
    Malfunction
    Date Received
    September 24, 2014
    Report Date
    September 11, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 04/15/2015 WITH THE FOLLOWING FINDINGS: THE KEYPAD COMPLAINT COULD NOT BE DUPLICATED. THERE WAS NO VISIBLE DAMAGE TO THE KEYPAD COVER. THE KEYPAD BUTTONS WERE NORMALLY RESPONSIVE, AND NO CONTAMINATION WAS OBSERVED UNDER THE KEYPAD BUTTON CONTACTS. THERE WAS MOISTURE OBSERVED IN THE CARTRIDGE COMPARTMENT. THE LEAK TEST FAILED DUE TO A MISSING AUDIO BOLUS BUTTON COVER. UNRELATED TO THE INITIAL COMPLAINT, 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.

    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 BUTTON/KEYPAD (TACTILE CHANGES W/MOISTURE) ISSUE. THE REPORTER ALLEGED THAT THE OK, UP AND DOWN ARROW KEYPAD BUTTONS WERE UNDER RESPONSIVE, AND THAT THERE WAS UNDER DELIVER OF INSULIN DUE TO THE KEYPAD ISSUE. IT WAS REPORTED THAT THERE WAS EVIDENCE OF MOISTURE IN THE CARTRIDGE COMPARTMENT. 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
    595092 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR