BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3900946 · Received June 27, 2014

    Report

    Report Number
    3004209178-2014-86305
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    May 5, 2014
    Report Date
    June 16, 2014
    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 PASSED THE DISPLACEMENT, PRIME, AND EXCESSIVE NO DELIVERY ALARM TEST. HOWEVER, THE DEVICE ALARMED DURING THE BASIC OCCLUSION TEST AS A RESULT OF A LOOSE/FLUSH DRIVE SUPPORT DISK. NO MOTOR ERROR ALARMS NOTED. THE DEVICE WAS RECEIVED WITH BROKEN BELT CLIP SLOT. THE MOTOR WAS TESTED OUTSIDE THE DEVICE AND PASSED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP KEPT ALARMING MOTOR ERROR DURING BASAL. THE BLOOD GLUCOSE READING WAS 152MG/DL. THE CALLER STATED THAT THE DEVICE WAS NOT EXPOSED TO A HIGH MAGNETIC FIELD. 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
    377696 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR