BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4564759 · Received March 3, 2015

    Report

    Report Number
    2531779-2015-07229
    Event Type
    Malfunction
    Date Received
    March 3, 2015
    Report Date
    February 17, 2015
    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

    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

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 04/08/2015 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE HISTORY SETTINGS INDICATED THAT THE BOLUS REMINDER WAS SET TO ¿ON¿; POST BG/POST BOLUS SET TO 2 HOURS. DURING INVESTIGATION, THE ¿AFTER BOLUS¿ FEATURE WAS SET TO 1 HOUR IN THE REMINDER SETTINGS. A BOLUS WAS DELIVERED; AT THE ¿CONFIRM¿ SCREEN, THE REMINDER WAS MANUALLY SET TO ¿0¿ AND CONFIRMED. THE PUMP WAS MONITORED FOR A PERIOD OF 2 HOURS FOLLOWING THE CONFIRMATION AND THE PUMP DID NOT ALARM. WHEN THE BG REMINDER IS SET TO ¿0¿ IT ONLY SAVED FOR THAT BOLUS DELIVERY AND WILL NOT BE SAVED WHEN ADDITIONAL BOLUS¿ ARE DELIVERED. ALL KEYPAD BUTTONS RESPONDED APPROPRIATELY TO BUTTON PRESSES. THE COMPLAINT THAT THE PUMP WAS EMITTING A BG REMINDER ALARM AFTER SETTING THE REMINDER TO ¿0¿ WAS NOT ABLE TO BE DUPLICATED DURING INVESTIGATION. NO DEFECTS WERE FOUND.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (HISTORY/SETTINGS ISSUE) ISSUE. THE REPORTER STATED THAT WHEN THE BLOOD GLUCOSE REMINDER IS SET TO ¿0¿ AND THE REMINDER FEATURE IS CONFIRMED TO BE OFF, THE REMINDER FEATURE DOES NOT TURN OFF FOR THE PARTICULAR BOLUS. THE REPORTER STATED THIS HAS OCCURRED SEVERAL TIMES AND OCCURRED WHEN THE USER WAS ¿VERY POSITIVE¿ THAT THE ACTION WAS CONFIRMED AFTER SETTING THE TIME TO ¿0¿. THE REPORTER DENIED ANY BUTTON TACTILE ISSUES. 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
    146209 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR