BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3265129 · Received August 5, 2013

    Report

    Report Number
    2531779-2013-12430
    Event Type
    Malfunction
    Date Received
    August 5, 2013
    Report Date
    July 10, 2013
    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. 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

    FOLLOW-UP # 1 DATE OF SUBMISSION 12/12/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/04/2013 WITH THE FOLLOWING FINDINGS:A REVIEW OF THE DEVICE HISTORY INDICATED THAT AN UNCONFIRMED REPLACE CARTRIDGE ALARM DELAYED THE INSULIN ON BOARD (IOB) CALCULATION FOR THE 11 UNIT BOLUS REFERENCED IN THE COMPLAINT. THE PUMP IOB WAS SET TO 1.5 HOURS. A 10 UNIT AUDIO BOLUS AND NORMAL BOLUS WERE PERFORMED AND CORRECTLY REFLECTED ON THE IOB STATUS SCREEN. THE IOB DEPLETED TO 0 IN 1.5 HOURS. THE IOB CALCULATION COMPLAINT WAS NOT DUPLICATED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (INSULIN ON BOARD CALCULATION) ISSUE. THE PATIENT ALLEGED THAT IOB IS ON WITH A 4 HOURS DURATION. THE PATIENT STATED THAT THE REMAINING IOB IS SHOWING 9.8 UNITS 4 HOURS AFTER AN 11 UNIT BOLUS, BUT THAT BOLUS HISTORY CONFIRMED 11 UNITS AT (B)(6) 13 1156 AM IS THE ONLY BOLUS IN TODAY'S HISTORY. THE PATIENT DENIED TRAUMA OR MOISTURE TO THE PUMP. 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
    365216 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR