BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3556587 · Received January 7, 2014

    Report

    Report Number
    2531779-2014-00516
    Event Type
    Injury
    Date Received
    January 7, 2014
    Date of Event
    December 20, 2013
    Report Date
    December 22, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN REQUESTED FOR RETURN AT THIS TIME. 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) 2013, THE REPORTER CONTACTED ANIMAS ALLEGING THAT ON (B)(6) 2013 THE PATIENT HAD GONE TO THE EMERGENCY ROOM (ER) FOR ELEVATED BLOOD GLUCOSE (BG). THE PATIENT¿S BG PRIOR TO GOING TO THE ER WAS REPORTEDLY ¿HI¿ (>600MG/DL) AND THE PATIENT HAD AN UNSTEADY GAIT AND HAD PASSED OUT. MULTIPLE BOLUSES WERE REPORTEDLY GIVEN TO BRING BG DOWN. UPON ARRIVAL AT THE ER, THE PATIENT¿S BG WAS REPORTEDLY 505MG/DL. THE REPORTER DID NOT PROVIDE DETAILS ABOUT THE PATIENT¿S TREATMENT AT THE ER, BUT STATED THAT THE PATIENT¿S BG WAS ADDRESSED AND THE PATIENT AS DISCHARGED FROM THE ER WITH BG OF 268MG/DL. THE REPORTER STATED THAT THE PATIENT¿S BG REMAINED AROUND 200MG/DL BUT AT THE TIME OF THE CALL TO ANIMAS THE PATIENT¿S BG WAS UP TO 380MG/DL. THE REPORTER DENIED ANY SIGNS OR SYMPTOMS OF HYPERGLYCEMIA AND NOTED THAT THE PATIENT¿S BG WAS BEING TREATED WITH CORRECTION BOLUSES. CUSTOMER TECHNICAL SUPPORT (CTS) REVIEWED THE PUMP WITH THE REPORTER AND IT WAS DISCOVERED THAT THE TIME WAS OFF BY 12 HOURS, READING AM INSTEAD OF PM, AND THE DATE WAS OFF BY A DAY, READING (B)(6) 2013 INSTEAD OF (B)(6) 2013. A REVIEW OF THE BASAL SETTINGS INDICATED THAT THE PATIENT GETS A HIGHER BASAL RATE OVERNIGHT AS COMPARED WITH THE DAYTIME SETTING. DURING TROUBLESHOOTING, THE REPORTER INTENTIONALLY REBOOTED THE PUMP AND CONFIRMED THAT THE TIME AND DATE HELD PROPERLY. THE REPORTER STATED THAT THE TIME/DATE ISSUE WAS LIKELY AN INADVERTENT PROGRAMMING ERROR BY THE PATIENT. THERE WAS NO PUMP DEFECT FOUND UPON TROUBLESHOOTING. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA REQUIRING MEDICAL INTERVENTION RELATED TO USE ERROR WHILE USING INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9917 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Life Threatening| R