BEUDAMED
    FDA Adverse Event Summary report: N

    PARADIGM REAL -TIME INSULIN INFUSION PUMP

    MDR report key: 4383708 · Received November 1, 2014

    Report

    Report Number
    2032227-2014-46234
    Date Received
    November 1, 2014
    Date of Event
    July 5, 2014
    Report Date
    October 9, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINDINGS: UNIT ALARMED A64 DURING SELF TEST DUE TO FAULTY Y1 ON RF BOARD. UNIT RECEIVED WITH MINOR SCRATCHED LCD WINDOW AND CRACKED RESERVOIR TUBE LIP. OZ (B)(4) 2014. 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-TIM INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED AN A64 ALARM ON HER INSULIN PUMP. HER BLOOD GLUCOSE WAS UNK AT THE TIME OF REPORTING. THE INSULIN PUMP WAS RETURNED. NO ADD'L INFO WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700507 PARADIGM REAL -TIME INSULIN INFUSION PUMP OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-554WWL

    Patients

    Seq Age Sex Outcome Treatment
    1