BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4231280 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48464
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    September 17, 2014
    Report Date
    October 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH LOOSE PROTRUDED DRIVE SUPPORT DISK, CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHES ON DISPLAY WINDOW AND CRACKED CASE NEAR DISPLAY WINDOW CORNERS NOTED DURING VISUAL INSPECTION.

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE DRIVE SUPPORT CAP ON HIS INSULIN PUMP IS COMING OUT. THE ISSUE STARTED ABOUT THREE WEEKS AGO WHILE MANUAL PRIME. IT HAS BEEN POPPING OUT MORE RECENTLY AND HE PUSHES IT IN. CUSTOMER PUSHES IT IN WHILE CONNECTED, EVEN THOUGH HE KNOWS HE'S NOT SUPPOSED TO DO THAT. CUSTOMER'S LAST BLOOD GLUCOSE WAS 240 MG/DL. HE WAS ADVISED THE DEVICE NEEDS TO BE REPLACED, AND TO DISCONTINUE USE AND REVERT TO A BACK UP PLAN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715437 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR