BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2070770 · Received April 14, 2011

    Report

    Report Number
    2531779-2011-02602
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Report Date
    March 18, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORTER REPORTED THAT THE PT NOTED THE INSULIN PUMP CHANGED THE DATE/TIME FOUR TIMES OVER THE PAST TWO MONTHS. ON AN UNSPECIFIED DATE, THE PT OBTAINED THE BLOOD GLUCOSE READING OF 11.0 MMOL/L (198 MG/DL) AND HE EXPERIENCED THE SYMPTOMS OF NAUSEA AND THIRST; HE WAS NEGATIVE FOR URINARY KETONES. THE PT CORRECTED HIS BLOOD GLUCOSE LEVEL USING A BOLUS INSULIN DOSE VIA THE PUMP; HE DID NOT SEEK ANY MEDICAL ATTENTION. TROUBLESHOOTING REVEALED THE PUMP PROGRAMMING HAD NOT BEEN CHANGED, AND DUE TO THE INCORRECT TIME, THE PT'S BASAL RATE WAS INCORRECT. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM LZG ANIMAS CORPORATION ONE TOUCH PING NA

    Patients

    Seq Age Sex Outcome Treatment
    1