BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3041662 · Received April 8, 2013

    Report

    Report Number
    3004209178-2013-92406
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 10, 2013
    Report Date
    March 22, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP ALARMED MOTOR ERROR DURING THE BASIC OCCLUSION 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 REGARDING ISSUES DURING PRIME/REWIND. THE BLOOD GLUCOSE READING WAS 121MG/DL. THE CALLER STATED THAT INSULIN SQUIRTED OUT DURING THE MANUAL PRIME PROCESS, AND THE INSULIN PUMP ALARMED. THE CUSTOMER MENTIONED THAT THE DRIVE SUPPORT CAP APPEARS NORMAL. 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
    143164 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR