BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3844223 · Received June 2, 2014

    Report

    Report Number
    2032227-2014-02843
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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 AND CRACKED RESERVOIR TUBE.

    Description of Event or Problem · 1

    CUSTOMER INITIALLY CALLED TO REPORT THAT HIS INSULIN PUMP WAS MALFUNCTIONING. CUSTOMER STATED THAT HIS INSULIN PUMP WAS TIED TO HIS LEG AND WHEN HE WOKE UP THE RESERVOIR WAS EMPTY AND THE INSULIN PUMP WAS UNABLE TO EXIT FROM PREPARING TO PRIME LOOP. CUSTOMER MENTIONED THAT HE HAD LOW BLOOD GLUCOSE. PARAMEDICS WERE CALLED AND CUSTOMER WAS HOSPITALIZED. THE BLOOD GLUCOSE READING WAS 20 MG/DL WHEN THE PARAMEDICS ARRIVED. CUSTOMER STATED THAT HE HAD HIGH BLOOD GLUCOSE OF 557 MG/DL USED THE BOLUS WIZARD TO TREAT WITH 10 UNITS OF INSULIN AND 3 HOURS LATER HE COULDN'T MOVE AND HIS MOTHER CALLED THE PARAMEDICS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322274 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization