BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4213127 · Received October 30, 2014

    Report

    Report Number
    2531779-2014-30862
    Event Type
    Injury
    Date Received
    October 30, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 13, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN REQUESTED TO BE 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 AND ALLEGED THAT ON (B)(6) 2014, THE PATIENT EXPERIENCED A BLOOD GLUCOSE (BG) OVER 500 MG/DL WITH A RACING HEART, RAPID, DEEP BREATHING/SHORTNESS OF BREATH AND/OR CHEST PAIN ASSOCIATED WITH AN INTERMITTENT POWER ISSUE. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED, DISCONTINUED PUMP THERAPY, AND WAS TREATED BY THEIR HEALTHCARE PROVIDER WITH INSULIN VIA INJECTION AND IV FLUIDS. REPORTEDLY, THE PATIENT HAD A SMALL CARDIAC BLOCKAGE. DURING TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT (CTS), IT WAS REVEALED THAT THE PATIENT HAD EXPERIENCED INTERMITTENT POWER DUE TO INCORRECTLY TIGHTENING THE BATTERY CAP ONTO THE PUMP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPERGLYCEMIA RELATED TO USE ERROR IN NOT PROPERLY SECURING THE BATTERY CAP TO THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696309 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening