BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3812915 · Received May 15, 2014

    Report

    Report Number
    2032227-2014-02370
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    October 9, 2012
    Report Date
    April 24, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN RECEIVED WHICH WAS NOT INCLUDED WITH THE INITIAL REPORT. THE INFORMATION HAS BEEN PROVIDED WITH THIS REPORT. THE INSULIN PUMP PASSED THE DELIVERY ACCURACY TEST.

    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SHE HAD UNEXPLAINED HIGH BLOOD GLUCOSE. PARAMEDICS WERE CALLED AND CUSTOMER WAS TAKEN TO THE HOSPITAL. CUSTOMER STATED THAT THE BLOOD GLUCOSE READING WAS 1600 MG/DL WHEN PARAMEDICS ARRIVED. CUSTOMER REPORTED THAT SHE WAS IN A DIABETIC COMA AND HER NEIGHBOR CALLED THE PARAMEDICS. CUSTOMER STATED THAT SHE HAD A BONE DENSITY SCAN WHILE WEARING THE INSULIN PUMP. CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT WORKING CORRECTLY, IT WAS UNABLE TO EXIT THE PREPARING TO PRIME LOOP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290362 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization