BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3903900 · Received June 30, 2014

    Report

    Report Number
    2531779-2014-18707
    Event Type
    Injury
    Date Received
    June 30, 2014
    Report Date
    June 24, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/14/2014 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE LAST BASAL DELIVERY WAS ON (B)(4) 2014 AT 12:50PM. THE BLACK BOX SHOWS SEVERAL ¿NO CARTRIDGE DETECTED¿ WARNINGS ON (B)(4) 2014. TOTAL DAILY DOSE ADDS UP AND REFLECTS THE PROGRAMMED BASAL RATE TARGET. THE DISPLAY IS DIM AND FADED; THE PISTON WAS UNABLE TO RECOGNIZE THE CARTRIDGE UPON THE FIRST LOAD ATTEMPT. THE COVER WAS REMOVED AND MOISTURE CORROSION WAS FOUND TO THE PCB ON THE U2 COMPONENT, THE FORCE SENSOR FLEX PINS AND FORCE SENSOR PLATE. FORCE SENSOR RESISTANCE IS WITHIN SPECIFICATIONS AT 9.4K OHMS. 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 PATIENT CONTACTED ANIMAS ON (B)(6) 2014 ALLEGING PRIME (LOAD STEP MALFUNCTION) ISSUE. THE PATIENT REPORTED THAT THEIR BLOOD GLUCOSE (BG) WAS 38MG/DL AND WAS UNABLE TO GET BG ABOVE 60MG/DL FOR A PERIOD OF ABOUT FOUR TO FIVE HOURS. THE PATIENT STATED THAT THEY WERE UNSURE HOW MUCH WAS INFUSED INTO THEM. THE PATIENT STATED THAT THERE WAS A FILLED CARTRIDGE IN PUMP. THE PATIENT CONFIRMED THAT THE PUMP WAS PRIMING TUBING DURING LOAD STEP. THIS REPORT IS BEING MADE DUE TO BG EXCURSION, THE PATIENT EXPERIENCED DUE TO AN ALLEGED LOAD STEP MALFUNCTION ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380730 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Life Threatening