BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3100523 · Received May 8, 2013

    Report

    Report Number
    3004209178-2013-93222
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    March 12, 2013
    Report Date
    April 12, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. UNIT WAS RECEIVED WITH SCRATCHED DISPLAY WINDOW.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE PARAMEDICS WERE CALLED AND SHE WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE. CUSTOMER STATED THAT THE BLOOD GLUCOSE READING WAS 32 MG/DL WHEN PARAMEDICS ARRIVED. CUSTOMER STATED THAT SHE HAD HIGH BLOOD GLUCOSE BETWEEN 200 AND 300 MG/DL AND OVER BLOUSED. CUSTOMER STATED THAT SHE HAD A SEIZURE DUE TO LOW BLOOD GLUCOSE PRIOR TO HOSPITALIZATION. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200914 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization