BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP MMT-715NAL

    MDR report key: 1974363 · Received January 21, 2011

    Report

    Report Number
    2032227-2011-00162
    Event Type
    Injury
    Date Received
    January 21, 2011
    Date of Event
    December 22, 2010
    Report Date
    December 22, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE WENT TO HIS DOCTOR AFTER EXPERIENCING HIGH BLOOD GLUCOSE LEVELS FOR THE PAST MONTH. THE CUSTOMER'S INSULIN AND INFUSION SETS WERE CHANGED, BUT HE CONTINUED TO EXPERIENCE ELEVATED BLOOD GLUCOSE LEVELS. THE CUSTOMER'S DOCTOR FELT THAT THE INSULIN PUMP WAS NOT DELIVERING THE CORRECT AMOUNT OF INSULIN, AND REQUESTED A REPLACEMENT INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME TEST, BUT NOT MUCH INSULIN CAME OUT DURING THE TEST. THE INSULIN PUMP PASSED THE DISPLACEMENT TEST. THE CUSTOMER ALSO REPORTED MOTOR ERROR ALARMS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN INFUSION PUMP MMT-715NAL INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization