BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2090939 · Received May 2, 2011

    Report

    Report Number
    2032227-2011-01115
    Event Type
    Injury
    Date Received
    May 2, 2011
    Date of Event
    April 22, 2011
    Report Date
    April 22, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    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

    THE CUSTOMER REPORTED THAT SHE WAS TREATED BY THE PARAMEDICS DUE TO A LOW BLOOD GLUCOSE READING OF 20 MG/DL. THE CUSTOMER STATED THAT HER GLUCOSE METER WAS GIVING INCORRECT READINGS. THE CUSTOMER WAS TREATING WHAT SHE THOUGHT WERE HIGH BLOOD GLUCOSE LEVELS. FOUND THAT THE CUSTOMER WAS USING TEST STRIPS THAT HAD BEEN EXPIRED FOR TWO YEARS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-522LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization