BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3191804 · Received June 26, 2013

    Report

    Report Number
    3004209178-2013-95089
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 27, 2013
    Report Date
    June 11, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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 PROTRUDED/LOOSE DRIVE SUPPORT DISK. UNABLE TO CONFIRM THE ALARM. THE DEVICE HAD A CRACKED DISPLAY WINDOW AND CRACKED CASE AT THE SCREEN CORNERS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING ISSUES DURING PRIME/REWIND. THE BLOOD GLUCOSE READING WAS 287MG/DL. THE CALLER STATED THAT INSULIN SQUIRTED OUT DURING THE MANUAL PRIME PROCESS, AND THE INSULIN PUMP ALARMED. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS SLIGHTLY INDENTED. ADVISED THE CUSTOMER 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
    291001 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR