BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2840966 · Received November 20, 2012

    Report

    Report Number
    2531779-2012-13820
    Event Type
    Injury
    Date Received
    November 20, 2012
    Report Date
    October 27, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 OBTAINED "HIGH" BLOOD GLUCOSE LEVELS AND HAD BEEN ADMITTED TO THE ICU. THE REPORTER NOTED THE PATIENT HAD RUN OUT OF IPT SUPPLIES, AND HER REORDER SHIPMENT HAD NOT YET ARRIVED. THE PATIENT'S HCP REPORTEDLY ORDERED THE PATIENT TO BE ON IPT INSTEAD OF INJECTIONS. THE TECHNICAL SUPPORT REPRESENTATIVE CONTACTED THE REPORTED TO TROUBLESHOOT THE PUMP AND TO OBTAIN INFORMATION REGARDING THE PATIENT'S STATUS, HOWEVER WAS UNABLE TO REACH HER BY TELEPHONE. NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT'S TECHNIQUE WAS INCORRECT BY NOT HAVING SUFFICIENT SUPPLIES TO USE WITH HER INSULIN PUMP. HOWEVER, AS THE PATIENT ALLEGEDLY WAS HOSPITALIZED DUE TO HYPERGLYCEMIA AFTER THIS OCCURRED, 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 11 YR Hospitalization| L