BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2200805 · Received July 29, 2011

    Report

    Report Number
    3004209178-2011-82366
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    July 16, 2011
    Report Date
    July 16, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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 THEREFOR CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING LOW BLOOD GLUCOSE EPISODE PRIOR TO THE CALL, AND THE PARAMEDICS WERE CALLED. THE CUSTOMER STATED THAT THEY ARRIVED, BUT HAD NOT PROVIDED ANY TREATMENT, BECAUSE SHE TREATED HERSELF WITH GLUCOSE TABLETS. THE CUSTOMER STATED THAT HER GLUCOSE LEVEL WENT UP TO 168MG/DL. THE CUSTOMER IS NEW TO THE INSULIN PUMP AND SHE IS STILL CALCULATING HER INSULIN DOSAGE AND BOLUS DELIVERY AMOUNT. THE CUSTOMER STATED THAT HER LOW BLOOD GLUCOSE WAS DUE TO A POSSIBLE MISCALCULATION OF BOLUS DELIVERY FOR HER MEAL AS THE CARBOHYDRATES WERE PROVIDED TO HER FROM A THIRD PARTY. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention