BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2082797 · Received April 28, 2011

    Report

    Report Number
    3004209178-2011-81266
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 19, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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 REPORTED BEING HOSPITALIZED FOR LOW BLOOD GLUCOSE. THE CUSTOMER STATED THAT SHE PASSED OUT DURING A CEREMONY SHE WAS ATTENDING. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS REMOVED THAT NIGHT BY THE MEDICAL DOCTOR AND SHE HAS NOT BEEN SINCE THEN. THE CUSTOMER WAS RELEASED FROM THE HOSPITAL AND WAS NOT EVEN TAKING INSULIN THROUGH THE INSULIN PUMP OR MANUAL INJECTIONS BETWEEN (B)(6) THROUGH (B)(6). THE CUSTOMER WAS READMITTED AGAIN WITH LOW BLOOD GLUCOSE OF 16MG/DL. OFFERED TO TROUBLESHOOT THE DEVICE, BUT THE CUSTOMER HAS NOT BEEN CONNECTED FOR OVER A WEEK, AND SHE STILL CANNOT GET HER BLOOD GLUCOSE TO GO UP. ADVISED THE CUSTOMER TO SPEAK TO HER DOCTOR ABOUT THE SETTINGS AND IF SHE NEED TO ADJUST THEM, THEN SHE NEEDS TO CALL US BACK TO TEST THE INSULIN PUMP AT LATER TIME. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization