BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2193315 · Received July 26, 2011

    Report

    Report Number
    3004209178-2011-82282
    Event Type
    Injury
    Date Received
    July 26, 2011
    Date of Event
    July 9, 2011
    Report Date
    July 11, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING LOW BLOOD GLUCOSE AND PARAMEDICS WERE CALLED. THE CUSTOMER'S BLOOD GLUCOSE READING WAS 47MG/DL, AND BY THE TIME HE GOT TO THE HOSPITAL HIS GLUCOSE READING WAS 202MG/DL. THE CUSTOMER WAS TREATED UNTIL HIS BLOOD GLUCOSE CAME STABLE. THE CUSTOMER ALSO STATED HAVING ANOTHER EPISODE OF LOW GLUCOSE OF 70MG/DL. THE CUSTOMER REQUESTED A REPLACEMENT OF THE INSULIN PUMP. IT WAS FOUND THAT THE CUSTOMER WAS NOT BOLUSING FOR MANY HOURS BEFORE HIS LOW BLOOD GLUCOSE. NO FURTHER INFORMATION 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 34 YR Hospitalization