BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4243753 · Received November 11, 2014

    Report

    Report Number
    2032227-2014-50433
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    July 20, 2014
    Report Date
    October 14, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PATIENT

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE INSULIN PUMP HAD AN UNUSUAL SPOT OR BLACK MARK ON THE SCREEN. CUSTOMER JUST WANTED THE DEVICE REPLACED DID NOT FEEL COMFORTABLE USING THE DEVICE. CUSTOMERS' BLOOD GLUCOSE WAS 73 MG/DL. CUSTOMER DID NOT RECALL HOW DAMAGE OCCURRED. CUSTOMER HAD A DIFFICULTY TIME TO EXPLAIN. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726867 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR