BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4233521 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48791
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    January 10, 2014
    Report Date
    February 7, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PUMP PASSED DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME/A33AND EXCESSIVE NO DELIVERY TEST. UNABLE TO VERIFY E70 ALARM IN ALARM HISTORY SCREEN DUE TO OVERWRITTEN HISTORY FILE. NO EXCESSIVE NO DELIVERY ALARM OR MOTOR ERROR ALARM NOTED. ALL OPERATING CURRENTS ARE WITHIN SPECIFICATION. OFF/NO POWER ALARM FUNCTION PROPERLY AND PASSED SELF TEST. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED. PUMP RECEIVED WITH CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHED LCD WINDOW AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP RETURNED MULTIPLE MOTOR ERROR ALARMS, NO DELIVERY ALARMS, AND BATTERY OUT LIMITS. BLOOD GLUCOSE LEVEL WAS 135 MG/DL AT THE TIME OF THE CALL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712925 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR