BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4183511 · Received October 18, 2014

    Report

    Report Number
    2032227-2014-40097
    Event Type
    Injury
    Date Received
    October 18, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 19, 2014
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    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. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED BEING HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS. CUSTOMER'S BLOOD GLUCOSE WAS IN THE AREA OF 600 MG/DL. CUSTOMER'S CURRENT BLOOD GLUCOSE READING WAS 387 MG/DL. NO SIGNIFICANT EVENTS LEADING TO THE ALARM WERE OBSERVED. ADVISED DISCONTINUATION OF THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663859 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MMT-522LNAL A1522LNALJ

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR