BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4180738 · Received October 17, 2014

    Report

    Report Number
    2531779-2014-29579
    Event Type
    Injury
    Date Received
    October 17, 2014
    Report Date
    October 4, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2015 WITH THE FOLLOWING FINDINGS: THE LAST BOLUS DELIVERY AND THE LAST BASAL DELIVERY WERE ON (B)(6) 2014. THE TOTAL DAILY DOSE PRIOR TO EVENT DATE ADDS UP CORRECTLY AND REFLECTS THE USERS PROGRAMMED BASAL RATES. THE ALARM HISTORY SHOWS TYPICAL USAGE ALARMS. A DELIVERY ACCURACY TEST WAS SUCCESSFULLY COMPLETED. THE PUMP WAS FOUND TO BE DELIVERING ACCURATELY AND WITHIN REQUIRED RANGE. INVESTIGATORS WERE UNABLE TO DUPLICATE THE COMPLAINT. THERE WAS NO DEFECT FOUND. 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

    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.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2014 REPORTING THAT THE PUMP FAILED AND DELIVERED INSULIN WHILE THEY WERE SLEEPING. THE PATIENT IS A QUESTIONABLE HISTORIAN AND REPORTING BOTH HIGH AND LOW BLOOD GLUCOSE (BG) LEVELS WITH NO SPECIFIC INFORMATION PROVIDED OTHER THAN THAT THEY WERE HOSPITALIZED IN THE ICU AND ON AN INSULIN DRIP AND THE PUMP WAS TAKEN AWAY BY HEALTHCARE PROFESSIONAL. AT THE TIME OF THIS CALL, THE PATIENT FELT THAT THE PUMP AND METER FAILED WHICH RESULTED IN HOSPITALIZATION HOWEVER THE PATIENT IS UNABLE TO PROVIDE SPECIFIC INFORMATION AND DOES NOT HAVE THE PUMP IN THEIR POSSESSION. THE PATIENT ALSO REPORTED THAT THEY HAVE HAD SIGNIFICANT WEIGHT LOSS RECENTLY. THE PATIENT STATED THAT THEY HAVE A HISTORY OF BIPOLAR DISORDER AND PREVIOUS HOSPITALIZATION RELATED TO BIPOLAR DISORDER AND STRESS. THIS REPORT IS BEING MADE DUE TO BG EXCURSION THE PATIENT EXPERIENCED WHILE ON INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662650 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization