BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4141841 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-32975
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED MOTOR ERROR AND PRIME REWIND ALARMS ON THE INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE WAS 161 MG/DL. DURING TROUBLESHOOTING FOR THE MOTOR ERROR ISSUE, IT WAS FOUND THAT THE INSULIN PUMP WAS NOT EXPOSED TO A STRONG MAGNETIC FIELD OR MAGNETIC RESONANCE IMAGING MACHINE. THE CUSTOMER DOES NOT USE THE SENSOR FEATURE ON THE INSULIN PUMP. SHE WAS UNABLE TO REWIND THE INSULIN PUMP AND WAS ADVISED TO DISCONTINUE USE AND REVERT TO A BACK-UP PLAN. THE CUSTOMER DECLINED TROUBLESHOOTING FOR THE PRIME REWIND ALARM. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621600 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR