BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2190382 · Received July 28, 2011

    Report

    Report Number
    2032227-2011-01834
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 12, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 CALLED TO REPORT THAT HE CANNOT HEAR THE AUDIBLE TONES ON THE INSULIN PUMP. THE CUSTOMER REPORTED AN INCIDENT WHERE HE EXPERIENCED LOW BLOOD GLUCOSE LEVELS. THE INSULIN PUMP WAS ALARMING, BUT HE COULD NOT HEAR THE ALARMS. HIS WIFE DID HEAR THE ALARMS, AND CALLED THE PARAMEDICS FOR ASSISTANCE. SUGGESTED VIBRATE FEATURE TO THE CUSTOMER. 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-722RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention