BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3771866 · Received April 24, 2014

    Report

    Report Number
    2531779-2014-11312
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Report Date
    April 10, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, A REVIEW OF THE BACK BOX AND ALARM HISTORY SHOWED 10U MANUAL ¿NORMAL¿ BOLUSES ON (B)(6) 2014. THE TOTAL DAILY DOSES CALCULATED CORRECTLY AND REFLECTED THE USER¿S BASAL TARGET. DURING TESTING, NO ¿AUTO-BOLUS¿ OCCURRED DURING THE DURATION TEST. ADVANCED BOLUSES WERE PERFORMED CORRECTLY AND RECORDED ACCURATELY IN THE BOLUS HISTORY. THE HISTORY SETTINGS ISSUE WAS NOT DUPLICATED DURING TESTING. THE KEYPAD IS UNDAMAGED AND THE KEYPAD BUTTONS RESPONDED APPROPRIATELY. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE DISPLAY WAS DIM AND DISCOLORED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (HISTORY/SETTINGS ISSUE) ISSUE. IT WAS REPORTED THAT THE PUMP DELIVERED TWO 10 UNIT BOLUSES WITHOUT USER INTERVENTION. THE PATIENT¿S BLOOD GLUCOSE (BG) LEVEL WAS REPORTED TO BE IN THE RANGE OF 40MG/DL TO 70MG/DL WITH NO SIGNS OR SYMPTOMS INDICATED. THE REPORTED BG WAS NOT INDICATIVE OF A SERIOUS INJURY AND DOES NOT MEET THE ANIMAS CRITERIA OF AN ADVERSE EVENT. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. IT WAS NOTED THAT THE PATIENT HAD LOST CONFIDENCE IN THE PUMP. THIS COMPLAINT IS BEING REPORTED DUE TO AN ALLEGED HISTORY SETTINGS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249935 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR