BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4221286 · Received November 3, 2014

    Report

    Report Number
    2531779-2014-31273
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Report Date
    October 18, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/26/2015 WITH THE FOLLOWING FINDINGS: THE BLACK BOX SHOWED EVIDENCE OF SEVERAL MANUAL TIME AND DATE CHANGES. THE TOTAL DAILY DOSES ADDED UP CORRECTLY. THE PUMP PASSED A DELIVERY ACCURACY TEST AND WAS FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATION AND DELIVERING ACCURATELY. A TIMEKEEPING ACCURACY TEST WAS PERFORMED AND THE PUMP MAINTAINED TIME ACCURATELY DURING A 5 DAY DURATION TEST, HOWEVER, WHEN THE PUMP WAS LEFT WITHOUT POWER FOR 1 HOUR, THEN POWERED BACK ON, IT HAD RETURNED TO THE DEFAULT TIME/DATE 12:00AM 01/01/2007. THE PUMP WAS OPENED FOR FURTHER INVESTIGATION AND AN INTERNAL CLOCK BATTERY MALFUNCTION WAS OBSERVED. THE RETURNED BATTERY CAP AND RETURNED CARTRIDGE CAP WERE USED TO COMPLETE TESTING.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS ALLEGING A HYPERGLYCEMIC EVENT ASSOCIATED WITH A HISTORY AND SETTINGS ISSUE. THE REPORTER STATED THAT ON (B)(6) 2014, IT WAS NOTED THAT THE PUMP HAD BEEN LOSING AND/OR GAINING MORE THAN 5 MINUTES OF TIME AS COMPARED TO AN ATOMIC CLOCK AND THAT THE PATIENT'S BLOOD GLUCOSE (BG) WAS 435MG/DL WITH NO REPORTED KETONES AND SYMPTOM OF NAUSEA. REPORTEDLY, NO TREATMENT WAS PROVIDED ABOVE AND BEYOND USUAL DIABETES MANAGEMENT, THE PATIENT'S HEALTHCARE PROVIDER HAD NOT MADE PUMP SETTING ADJUSTMENTS BEFORE OR AFTER THE ALLEGED EVENT AND PUMP USE WAS DISCONTINUED. THE REPORTED BG EXCURSION DOES NOT CONSTITUTE A SERIOUS ADVERSE EVENT. TROUBLESHOOTING DETERMINED THAT THERE WERE NO OTHER CONTRIBUTING FACTORS FOR THE ALLEGED COMPLAINT. THIS COMPLAINT IS BEING REPORTED FOR ALLEGED TIME LOSS/GAIN ISSUE FOR WHICH A PUMP MALFUNCTION COULD NOT BE RULED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701725 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR