BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3253365 · Received July 29, 2013

    Report

    Report Number
    3004209178-2013-96178
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 3, 2013
    Report Date
    July 3, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS UNABLE TO PRIME DURING THE PRIME TEST AS A RESULT OF A LOOSE DRIVE SUPPORT DISK. UNABLE TO CONFIRM THE ALARM. THE DEVICE HAD MISSING END CAP STICKER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP WAS STUCK IN THE PRIME LOOP AND ALARMED DURING THE PRIME PROCESS. THE BLOOD GLUCOSE READING WAS 184MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE DRIVE SUPPORT CAP WAS PROTRUDED. ADVISED THE CALLER TO DISCONTINUE THE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353146 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR