BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3022979 · Received March 27, 2013

    Report

    Report Number
    3004209178-2013-92128
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 10, 2013
    Report Date
    March 10, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PATIENT

    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 BEING HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE OF 450MG/DL, AND SHE HAD LOST HER INSULIN PUMP. THE CALLER WAS IN THE DOCTOR'S OFFICE AT TIME OF CALL, AND HER BLOOD GLUCOSE WAS BETWEEN 400 TO 600MG/DL. THE CUSTOMER STATED THAT SHE HAD A DENTAL IMPLANT, AND SHE IS IN A LOT OF PAIN AS WELL HER BLOOD GLUCOSE HAS BEEN INCREASED. THE CUSTOMER STATED THAT SHE HAD NOT EATEN, AND SHE WAS CRYING AND VERY UPSET. THE CUSTOMER DID NOT FEEL WELL TO PROVIDE FURTHER DETAILS ON HER ADMISSION. ATTEMPTED TO CALL HER BACK SEVERAL TIMES WITH NO RESULTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125727 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization