BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4223352 · Received November 4, 2014

    Report

    Report Number
    2032227-2014-46827
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    October 5, 2014
    Report Date
    October 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    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. 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. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC (B)(4). 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 PUMP WAS RECEIVED WITH A BLANK DISPLAY DUE TO A CORRODED BATTERY TUBE. THE PUMP ALSO HAD BROKEN BATTERY CAP THREADS AND A CORRODED BATTERY CAP CONTACT. UNABLE TO VERIFY FOR WEAK BATTERY ALARM DUE TO THE BLANK DISPLAY. NO MOISTURE DAMAGE INSIDE THE PUMP WAS NOTED. THE PUMP ALSO HAD MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED CASE AT THE DISPLAY WINDOW CORNERS, A CRACKED RESERVOIR TUBE LIP AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED A BLANK DISPLAY WHEN CHANGING THE INSULIN PUMP'S BATTERY. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT REPORTED. THE CUSTOMER ALSO REPORTED THAT THE CONTACTS ON THE BATTERY CAP ARE DAMAGED. THE PRODUCT WILL BE RETURNED. NOTHING FURTHER TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707243 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754CAS

    Patients

    Seq Age Sex Outcome Treatment
    1