BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3233090 · Received July 18, 2013

    Report

    Report Number
    2531779-2013-11258
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    June 22, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/23/2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. THE PUMP WAS UNABLE TO PERFORM A 29 HOUR FLOW ACCURACY TEST DUE TO A RECURRING CALL SERVICE ALARM. THE PUMP WAS EXAMINED AND A CRACK IN THE PUMP CASING WAS FOUND AT THE CASE SEAL. THE PUMP WAS OPENED AND MOISTURE DAMAGE WAS OBSERVED INSIDE THE PUMP. THE COMPLAINT WAS UNABLE TO BE FULLY INVESTIGATED DUE TO THE MOISTURE ISSUE. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE REPORTER CONTACTED ANIMAS TO REPORT THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH A DIAGNOSIS OF DKA, AND HIS BLOOD GLUCOSE LEVEL WAS ¿GREATER THAN 300 MG/DL¿. THE TECHNICAL SERVICE REPRESENTATIVE CONTACTED THE REPORTER TO OBTAIN INFORMATION AND TROUBLESHOOT THE PUMP, HOWEVER WAS UNABLE TO REACH HER BY TELEPHONE. NO INFORMATION WAS PROVIDED ABOUT THE PUMP OR THE PATIENT¿S STATUS PRIOR TO ADMISSION TO THE HOSPITAL. AS THE PATIENT ALLEGEDLY WAS HOSPITALIZED IN DKA WHILE USING THE PUMP, AND THE ISSUE WAS NOT RESOLVED, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336053 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Hospitalization| L