BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3873334 · Received June 13, 2014

    Report

    Report Number
    3004209178-2014-85769
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 24, 2014
    Report Date
    June 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. UNIT WAS RECEIVED WITH CRACKED DISPLAY WINDOW CORNER AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT SHE DOES NOT BELIEVE HER INSULIN PUMP IS FUNCTIONING PROPERLY. CUSTOMER STATES SHE HAD A BENT CANNULA AND THE DEVICE DID NOT ALARM. SHE ALSO STATED THAT SHE BELIEVES THE INSULIN PUMP IS DELIVERING TOO MUCH INSULIN, WHICH MAY BE THE REASON SHE IS HAVING HIGH BLOOD GLUCOSE LEVELS. CUSTOMER WAS ADVISED TO DISCONNECT FROM DEVICE. DURING TROUBLESHOOTING, CUSTOMER WAS ASKED TO CHECK THE CONDITION OF THE DRIVE SUPPORT CAP ON THE DEVICE AND FOUND IT TO BE NORMAL. CUSTOMER VERIFIED THERE WERE NO AIR BUBBLES. AFTERWARDS, RESERVOIR WAS REINSERTED INTO INSULIN PUMP AND A MANUAL PRIME WAS PERFORMED. INSULIN PUMP DID NOT ALARM AND CUSTOMER WAS ADVISED THE DEVICE WAS FUNCTIONING PROPERLY. AT THIS TIME, CUSTOMER CLARIFIED THAT CANNULA HAD NOT BEEN BENT, BUT INSTEAD THE INFUSION SET TUBING HAD A KNOT IN IT. BLOOD GLUCOSE LEVEL WAS 172 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349323 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 21 YR