BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522LNAL

    MDR report key: 1974342 · Received January 21, 2011

    Report

    Report Number
    2032227-2011-00206
    Event Type
    Injury
    Date Received
    January 21, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 6, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 HOSPITALIZED ON TWO SEPARATE OCCASIONS. ONCE IN (B)(6), AND AGAIN ON (B)(6), 2011. THE CUSTOMER DID NOT WANT TO PROVIDE FURTHER INFORMATION ABOUT THE HOSPITALIZATIONS OR TROUBLESHOOT. THE CUSTOMER DID MENTION THAT SHE WOULD LIKE TO TRY SAMPLES OF DIFFERENT INFUSION SETS DUE TO THE CANNULAS BEING BENT BOTH TIMES SHE WAS HOSPITALIZED. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization