BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 4173658 · Received October 15, 2014

    Report

    Report Number
    2032227-2014-38294
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    September 13, 2014
    Report Date
    September 15, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SHE WOKE UP WITH HIGH BLOOD GLUCOSE OF 420 MG/DL; LEVEL KEPT INCREASING AND SHE HAD TO TREAT WITH MANUAL INSULIN INJECTION. CUSTOMER STATED THAT SHE WAS IN THE HOSPITAL EMERGENCY ROOM DUE TO DIABETIC KETOACIDOSIS. CUSTOMER EXPERIENCED NAUSEA AND FATIGUE. CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF EMERGENCY ROOM VISIT. NO TROUBLESHOOT WAS PERFORMED AS THE CUSTOMER DID NOT HAVE THE INSULIN PUMP AT THE TIME. BLOOD GLUCOSE VALUE AT THE TIME OF THE ADMISSION WAS 326 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653950 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-512LNAB A000105537

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization