BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4123516 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29620
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 18, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY CUSTOMER THAT THEY HAD BEEN HOSPITALIZED FOR LOW BLOOD GLUCOSE LEVELS ON (B)(6) OF 2014. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 20 MG/DL AT TIME OF HOSPITALIZATION AND WAS GIVEN INTRAVENOUS INSULIN DRIP WHILE IN THE HOSPITAL. DURING TROUBLESHOOTING, CUSTOMER WAS ASKED TO CHECK THE CONDITION OF THE DRIVE SUPPORT CAP ON THE DEVICE AND FOUND IT TO BE NORMAL. NEXT, CUSTOMER WAS ASKED TO CHECK FOR AIR BUBBLES IN INFUSION SET TUBING. CUSTOMER VERIFIED THERE WERE NO AIR BUBBLES. AFTERWARDS, THE RESERVOIR WAS REINSERTED INTO INSULIN PUMP AND A MANUAL PRIME WAS PERFORMED. DEVICE PASSED PRIMING, HIGH PRESSURE TEST AND INSULIN EXITED TUBING. INFORMED CUSTOMER DEVICE IS FUNCTIONING PROPERLY. ADVISED TO CHANGE ENTIRE SET AND MONITOR DEVICE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600401 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization