BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2103778 · Received May 18, 2011

    Report

    Report Number
    2032227-2011-01263
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    April 26, 2011
    Report Date
    May 10, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 LOW BLOOD GLUCOSE LEVELS THAT CAUSED HIM TO PASS OUT. THE PARAMEDICS WERE CALLED, BUT THEY DID NOT ASSIST HIM. THE CUSTOMER HAD TREATED WITH ORANGE JUICE AND REGAINED CONSCIOUSNESS PRIOR TO THEIR ARRIVAL. THE CUSTOMER STATED THAT HIS GLUCOSE METER WAS NOT GIVING THE CORRECT READINGS, CAUSING HIM TO GIVE HIMSELF INSULIN UNNECESSARILY. THE CUSTOMER HAS RECEIVED A REPLACEMENT GLUCOSE METER FROM HIS HEALTHCARE PROFESSIONAL. 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-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention