BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2832515 · Received November 14, 2012

    Report

    Report Number
    2531779-2012-13614
    Event Type
    Injury
    Date Received
    November 14, 2012
    Report Date
    October 19, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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) 2012 THE REPORTER, THE PATIENT'S MOTHER, CONTACTED ANIMAS TO REPORT THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH A DIAGNOSIS OF DKA. NO FURTHER INFORMATION WAS PROVIDED. THE TECHNICAL SUPPORT REPRESENTATIVE CONTACTED THE REPORTER TO OBTAIN AND VERIFY INFORMATION AND TO TROUBLESHOOT THE PUMP; HOWEVER WAS UNABLE TO REACH HER BY TELEPHONE. NO TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP CANNOT BE RULED OUT AS A CONTRIBUTOR TO THE PATIENT'S SERIOUS INJURY. AS THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS AND/OR BLOOD GLUCOSE LEVELS SUGGESTING DKA WHILE USING THE PUMP, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION OTP GLUCOSE MGMT SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Hospitalization| L