BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3974001 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-89004
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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

    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. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ALL OPERATING CURRENTS WERE WITHIN SPECIFICATION. NO UNEXPECTED BLANK DISPLAY WAS NOTED. THE INSULIN PUMP PASSED THE DISPLACEMENT, REWIND, BASIC OCCLUSION, AND EXCESSIVE NO DELIVERY ALARM TESTS. THE INSULIN PUMP WAS UNABLE TO PRIME DURING THE PRIME TEST DUE TO A FAULTY FORCE SENSOR RESISTOR. NO ALARMS WERE NOTED FOR A LOOSE DRIVE SUPPORT DISK OR MOTOR ERRORS. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW, CRACKED RESERVOIR TUBE LIP AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP HAD AN ALARM FOR A MOTOR ERROR AND FOR A LOOSE DRIVE SUPPORT DISK, AND THAT THE SCREEN WENT BLACK. CUSTOMER STATED THAT THE MOTOR ERROR ALARM OCCURRED WHILE CHANGING THE BATTERY AND INFUSION SET. HE STATED THAT THE INSULIN PUMP HAD NOT BEEN DROPPED, BUMPED OR EXPOSED TO A STRONG MAGNETIC FIELD OR MRI. HE WAS UNABLE TO REWIND THE INSULIN PUMP. THE BLOOD GLUCOSE READING WAS 58 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451164 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR