BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2212958 · Received August 8, 2011

    Report

    Report Number
    2032227-2011-01982
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 7, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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'S HUSBAND CALLED TO FIND OUT THE RESULTS OF THE TESTING ON SENSORS THAT WERE RETURNED FOR ANALYSIS. THE HUSBAND ALSO STATED THAT THE CUSTOMER HAD TO SEEK MEDICAL ATTENTION TODAY WHILE SHE WAS AT WORK BECAUSE HER SENSOR DID NOT ALERT HER OF HIGH BLOOD GLUCOSE LEVELS. ADVISED THE CALLER THAT WE COULD NOT ASSIST HIM DUE TO (B)(6) REGULATIONS. ADVISED THE CALLER TO HAVE THE CUSTOMER CALL US FOR (B)(6) APPROVAL TO SPEAK WITH HIM. 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 52 YR Hospitalization