BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4120001 · Received September 25, 2014

    Report

    Report Number
    2032227-2014-29251
    Event Type
    Injury
    Date Received
    September 25, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 27, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    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

    IT WAS REPORTED BY CUSTOMER THAT THEY HAD BEEN HOSPITALIZED FOR LOW BLOOD GLUCOSE LEVELS ON IN FEBRUARY. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NEAR 30 MG/DL AT TIME OF HOSPITALIZATION AND WAS GIVEN INTRAVENOUS INSULIN DRIP WHILE IN THE HOSPITAL. CUSTOMER DECLINED TROUBLESHOOTING. ADVISED TO CHANGE ENTIRE SET AND MONITOR DEVICE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 182 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597805 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAH A000139228

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization