BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3873335 · Received June 13, 2014

    Report

    Report Number
    3004209178-2014-85732
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 17, 2014
    Report Date
    May 27, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    OTHER

    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 DISPLAY WINDOW CORNER, SCRATCHED LCD WINDOW, AND A CRACKED BELT CLIP SLOT AT BATTERY TUBE THREADS AREA AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED IN TO REPORT THAT SHE HAD BEEN HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 950 MG/DL. THE CALLER ALSO STATED THAT SHE RECEIVED A MOTOR ERROR ALARM. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349563 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization