BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4801433 · Received May 28, 2015

    Report

    Report Number
    3004209178-2015-60080
    Event Type
    Malfunction
    Date Received
    May 28, 2015
    Date of Event
    May 7, 2015
    Report Date
    May 7, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS UNABLE TO VIBRATE DUE TO A BROKEN WIRE. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED CASE AT THE DISPLAY WINDOW CORNER, MINOR SCRATCHES ON THE DISPLAY WINDOW, SCRATCHED RESERVOIR TUBE WINDOW, CRACKED BELT CLIP SLOT, CRACKED BATTERY TUBE THREADS AND A CRACKED RESERVOIR TUBE LIP.

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. 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

    A CUSTOMER REPORTED VIA PHONE CALL INDICATING THAT THEIR INSULIN PUMP STOPPED VIBRATING. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 3.8 MMOL/L AT THE TIME OF THE CALL. THE CUSTOMER STATED WAS ASSISTED WITH A SELF TEST BUT THE INSULIN PUMP ONLY BEEPED. THE INSULIN PUMP DID NOT VIBRATE. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347107 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754WWL

    Patients

    Seq Age Sex Outcome Treatment
    1