BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4141177 · Received October 3, 2014

    Report

    Report Number
    2032227-2014-32766
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE MORNING THE CUSTOMER'S BLOOD GLUCOSE WAS 353; IT WAS TREATED WITH A CORRECTION OF 5.5 UNITS. CUSTOMER THEN HAD BREAKFAST AND GAVE AN INSULIN BOLUS OF 6.5 UNITS. BLOOD GLUCOSE VALUE WAS CONTINUING TO RISE; IT WENT UP TO 512 MG/DL; TREATED WITH MANUAL INSULIN INJECTION. DURING TROUBLESHOOT; IT WAS STATED THE DRIVE SUPPORT CAP IS FLUSH. IT WAS STATED THAT THE CUSTOMER FELL THE WEEK BEFORE AND HIT HER HEAD; THEY HAD TO GO TO A SCAN. CUSTOMER GOT BACK IN CONTACT AND STATED THAT IT WAS FOUND THAT THERE WERE AIR BUBBLES HALF WAY OF THE TUBING. CUSTOMER WAS ABLE TO REWIND AND PERFORM MANUAL PRIME, INSULIN DID EXIT THE TUBING. NO INSULIN LEAKS FOUND. CUSTOMER STATED THAT TIME, DATE, BASAL RATES AND BOLUS WIZARD ARE SET UP CORRECTLY. INSULIN PUMP PASSED THE HIGH PRESSURE TEST. IT WAS ADVISED THAT THE CUSTOMER SHOULD CHANGE THE INFUSION SET AND RESERVOIR. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619625 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723RNAL A0723RNALJ

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR