BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4142276 · Received October 5, 2014

    Report

    Report Number
    2032227-2014-33403
    Event Type
    Malfunction
    Date Received
    October 5, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 5, 2014
    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

    (B)(4).CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND 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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH A BROKEN RESERVOIR TUBE LIP, A CRACKED CASE AT THE DISPLAY WINDOW CORNERS, A CRACKED CASE AT THE RESERVOIR TUBE WINDOW CORNERS, MINOR SCRATCHES ON THE DISPLAY WINDOW AND A MISSING END CAP STICKER. NO ERROR ALARMS WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOMER FEEL OFF THE STAIRS AND THE CASING OF THE INSULIN PUMP GOT DAMAGED. THE PLACE WHERE THE RESERVOIR ATTACHES WAS LOOSE, CURRENTLY BEING HELD WITH TAPE. THE LOOKING GLASS WAS ALSO CRACKED. AFTER BATTERY CHANGES THE DEVICE ALARMS UNEXPECTED RESTARTS AND EXTERNAL RAM ERROR. CUSTOMER'S BLOOD GLUCOSE WAS 10.2MMOL/L. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622078 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-554WWS

    Patients

    Seq Age Sex Outcome Treatment
    1