BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4223098 · Received November 4, 2014

    Report

    Report Number
    2032227-2014-47414
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    December 19, 2013
    Report Date
    December 19, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PUMP PASSED A21 ALARM TEST. NO A21 ALARMS OR A17 ALARMS NOTED. NO A47 ALARMS NOTED DURING TESTING. HOWEVER A47 ALARMS NOTED IN ALARM HISTORY DUE TO CORRUPTED HISTORY FILES. UNABLE TO DOWNLOAD PROPERLY DUE TO A47 ALARMS. CRACKED RESERVOIR TUBE LIP AND MINOR SCRATCHES ON DISPLAY WINDOW NOTED DURING VISUAL INSPECTION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP WAS NOT COMPLETING THE UPLOAD PROCESS TO CARELINK. CUSTOMER REPORTED THAT THE INSULIN PUMP'S ALARM HISTORY SHOWED MULTIPLE ERROR ALARMS. BLOOD GLUCOSE LEVEL WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706225 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR