BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4133806 · Received October 1, 2014

    Report

    Report Number
    2531779-2014-28061
    Event Type
    Injury
    Date Received
    October 1, 2014
    Report Date
    September 19, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: A TIME/DATE RESET TO THE DEFAULT SETTINGS COULD NOT BE VERIFIED IN THE BLACK BOX HISTORY. EVALUATION REVEALED THE INTERNAL CLOCK BATTERY ON THE PCB BOARD HAD FAILED. THE PUMP WOULD NOT RETAIN THE USER PROGRAMMED DATE AND TIME SETTINGS UPON REMOVAL OF THE PRIMARY AA BATTERY. WHEN A NEW AA BATTERY IS INSERTED THE PUMP DISPLAYS THE DEFAULT DATE AND TIME WHICH MUST BE MANUALLY CONFIRMED (OR RESET) BY THE USER IN ORDER TO PROCEED. THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER¿S PROGRAMMED BASAL RATES AND A DELIVERY ACCURACY TEST WAS SUCCESSFULLY COMPLETED. UNRELATED TO THE ORIGINAL COMPLAINT, THE DISPLAY HAD A PINKISH CONTRAST. 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.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2014 ALLEGING THAT THE PUMP¿S TIME AND DATE DEFAULTED TO FACTORY SETTINGS. THIS IS BEING RULED OUT BASED ON THE FOLLOWING: THE PATIENT STATED THAT THE TIME AND DATE DEFAULTED TO FACTORY SETTINGS AFTER THE BATTERY WAS REPLACED. THE PUMP DISPLAYS THE VERIFY SCREEN AFTER IT IS REBOOTED AND THE TIME AND DATE MUST BE SET TO CONFIRM THE VERIFY SCREEN. THE ISSUE IS NOT LIKELY TO CAUSE AN ADVERSE EVENT. THE REPORTER STATED THAT THE PATIENT HAD A BLOOD GLUCOSE (BG) OF 23MG/DL. EMERGENCY MEDICAL SERVICES PROTOCOL WAS INITIATED AND THE PATIENT WAS TAKEN TO THE HOSPITAL. THEY WERE TREATED WITH IV GLUCOSE, IV FLUIDS AND A GLUCAGON INJECTION. THIS REPORT IS BEING MADE DUE TO THE BG EXCURSION THE PATIENT EXPERIENCED WHILE ON INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611159 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization