BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3873320 · Received June 13, 2014

    Report

    Report Number
    3004209178-2014-85774
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 27, 2014
    Report Date
    June 10, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 A CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP, SCRATCHED LCD WINDOW AND SCRATCHED RESERVOIR TUBE WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT HE HAD BEEN HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS. CUSTOMER STATED FEELING WEAK AND COULD NOT WALK. BLOOD GLUCOSE LEVEL AT TIME OF HOSPITALIZATION WAS OVER 600 MG/DL AND HE WAS TREATED WITH AN INTRAVENOUS INSULIN DRIP. CUSTOMER WAS ADVISED TO DISCONNECT FROM PUMP. DURING TROUBLESHOOTING, CUSTOMER WAS ASKED TO CHECK THE CONDITION OF THE DRIVE SUPPORT CAP ON THE DEVICE AND FOUND IT TO BE NORMAL. AFTERWARDS, RESERVOIR WAS REINSERTED INTO INSULIN PUMP AND A MANUAL PRIME WAS PERFORMED. INSULIN EXITED TUBING. INSULIN PUMP DID NOT ALARM AND CUSTOMER WAS ADVISED THE DEVICE WAS FUNCTIONING PROPERLY. INFORMED CUSTOMER THAT BOLUS DOES NOT RESUME AFTER TAKING INSULIN PUMP OFF SUSPEND. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349558 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization