BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2140447 · Received June 16, 2011

    Report

    Report Number
    3004209178-2011-81820
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR LOW BLOOD GLUCOSE. THE BLOOD GLUCOSE READING AT TIME OF CALL WAS 30MG/DL. TROUBLESHOOTING WAS PERFORMED. IT WAS STATED THAT THE CUSTOMER BOLUSED 20.0 UNITS LATE IN THE EVENING, AND LATER HIS GLUCOSE LEVEL DROPPED. THE CUSTOMER'S MOST RECENT GLUCOSE READING WAS 325MG/DL, BUT HE WAS MONITORED AND BOLUSING AS NEEDED. 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 57 YR Hospitalization