BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2832519 · Received November 14, 2012

    Report

    Report Number
    3004209178-2012-90713
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 30, 2012
    Report Date
    October 30, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    CGA
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH NORMAL OPERATING CURRENTS AND NO OFF/NO POWER, LOW BATTERY, WEAK BATTERY OR FAILED BATTERY TEST ALARMS NOTED. THE INSULIN PUMP HAD BUTTON ERROR ALARM DUE TO MOISTURE DAMAGE ON KEYPAD TRACES. THE INSULIN PUMP HAD MOTOR ERROR ALARM DURING OCCLUSION TEST AND UNABLE TO PRIME DURING PRIME TEST DUE TO MOISTURE DAMAGE INSIDE FORCE SENSOR. THE INSULIN PUMP PASSED DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, AND NO DELIVERY TESTS. NO EXCESSIVE NO DELIVERY ALARM NOTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR. TROUBLESHOOTING WAS PERFORMED, AND THE DISPLACEMENT TEST PASSED. ASSISTED THE CUSTOMER WITH MANUALLY PRIMING THE INSULIN PUMP, AND THE DEVICE ALARMED MOTOR ERROR. THE CALLER STATED WHILE PRIMING, THE DEVICE RAN UP TO 19.0 UNITS AND NO INSULIN DID EXIT, BUT SHE DID NOT RECEIVE ANY ALARM. THE TUBING CLAMP WAS NOT AVAILABLE AT TIME OF CALL AND THE CUSTOMER REQUESTED THE DEVICE BE REPLACED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP OYC CGA MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR