BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4173824 · Received October 15, 2014

    Report

    Report Number
    2032227-2014-38348
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 15, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH CRACKED AND BLEEDING LCD GLASS, MINOR SCRATCHES ON DISPLAY WINDOW, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP. INSULIN PUMP WAS UNABLE TO PERFORM MINILINK TRANSMITTER TEST DUE TO LCD DAMAGED.

    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. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP HAD A CRACK IN THE CENTER OF THE SCREEN MAKING THE SCREEN DIFFICULT TO READ. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 5.8 MMOL/L. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655613 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-554LCMS

    Patients

    Seq Age Sex Outcome Treatment
    1