BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3760381 · Received April 21, 2014

    Report

    Report Number
    2531779-2014-10568
    Event Type
    Injury
    Date Received
    April 21, 2014
    Report Date
    March 30, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS AT THE TIME OF THIS REPORT. 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 DEVICE HAS BEEN RETURNED AND EVALUATED BY ANIMAS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: NO EVIDENCE OF CANCELLED OR UNDELIVERED BOLUSES WAS OBSERVED IN THE BLACK BOX. ACCORDING TO THE TOTAL DAILY DOSE HISTORY IT APPEARED THAT THE DATE WAS MANUALLY MANIPULATED ON (B)(6) 2014. A 10 UNIT AUDIO AND A 10 UNIT NORMAL BOLUS WERE SUCCESSFULLY PERFORMED FROM THE PUMP AND ACCURATELY RECORDED IN THE PUMP HISTORY. THE PUMP WAS PAIRED WITH A TEST METER AND WAS ABLE TO DELIVER A BOLUS WITH NO ISSUES. 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

    (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2014, A REPORTER CONTACTED ANIMAS ALLEGING THAT ON AN UNSPECIFIED DATE, THE PATIENT HAD EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS (ABOVE 250 MG/DL) WITH UNSPECIFIED KETONES. THE REPORTER STATED THAT DURING A VISIT WITH THEIR HEALTHCARE PROVIDER, IT WAS DISCOVERED THAT THERE WERE MISSING BOLUSES IN THE PUMP HISTORY THAT THE REPORTER WAS CERTAIN WERE DELIVERED. THE REPORTER ALLEGED THAT THE MISSING BOLUSES WERE SENT FROM BOTH THE PUMP AND THE METER. ADDITIONALLY THE REPORTER STATED THAT THE HEALTHCARE PROVIDER NOTED THAT PREVIOUS CHANGES TO THE PROGRAMMED BASAL RATES HADN'T BEEN SAVED TO THE PUMP AND HAD REMAINED THE SAME SINCE 2013. THE HEALTHCARE PROVIDER ALLEGEDLY THEN CHANGED THE PUMP¿S BASAL RATE AS WELL AS THE INSULIN TO CARBOHYDRATE RATIO, INSULIN SENSITIVITY FACTOR, AND BLOOD GLUCOSE TARGET VALUES. THIS COMPLAINT IS BEING REPORTED BASED ON ALLEGATIONS OF THE PUMP CONTRIBUTING TO THE PATIENT¿S HYPERGLYCEMIA RELATING TO THE ALLEGED SETTINGS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240533 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Life Threatening