BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2822189 · Received November 7, 2012

    Report

    Report Number
    2032227-2012-07647
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    July 10, 2012
    Report Date
    July 11, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS UNABLE TO PRIME DURING THE PRIME TEST DUE TO A LOOSE DRIVE SUPPORT DISK. UNABLE TO VERIFY ANY ALARMS OR CONDUCT THE OCCLUSION TEST DUE TO THE PRIME ANOMALY.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED IN WITH A HIGH BLOOD GLUCOSE READING OF 465 MG/DL. THE CUSTOMER ALSO REPORTED HEADACHES AND NAUSEA. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP ALARMED, AND DID NOT DELIVER ANY INSULIN DURING THE MANUAL PRIME. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP OYC OYC MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR