BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4052901 · Received September 2, 2014

    Report

    Report Number
    2032227-2014-15914
    Event Type
    Injury
    Date Received
    September 2, 2014
    Date of Event
    August 2, 2014
    Report Date
    August 3, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE PUERTO RICO 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. SEE MEDWATCH REPORT 2032227-2014-15917 UNDER THE RESERVOIR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAS BEEN EXPERIENCING HIGH BLOOD GLUCOSE AND HAD DIFFICULTY DECREASING THE LEVEL. CUSTOMER HAD TO RETRIEVE TO MANUAL INSULIN INJECTIONS. BLOOD GLUCOSE VALUE IS OVER 600 MG/DL. CUSTOMER EXPERIENCED VOMITING. CUSTOMER'S MOTHER STATED THEY CONTACTED THE DOCTOR. DURING TROUBLESHOOT; IT WAS STATED THE DRIVE SUPPORT CAP IS RECESSED. CUSTOMER WAS ABLE TO REWIND AND PERFORM MANUAL PRIME. CUSTOMER DID NOT FIND AN INSULIN LEAK. CUSTOMER STATED THAT TIME, DATE, BASAL RATES AND BOLUS WIZARD ARE SET UP CORRECTLY. INSULIN PUMP PASSED THE HIGH PRESSURE TEST. NO ERROR ALARMS FOUND IN THE HISTORY AND BOLUS HISTORY IS ACCURATE. CUSTOMER STATED THE TUBING HAS NO AIR BUBBLES BUT THERE ARE SMALL BUBBLES IN THE RESERVOIR; THE INSULIN PUMP WAS REWOUND WITH THE RESERVOIR INSERTED. CUSTOMER HAS CHANGED THE INFUSION SET SEVERAL TIMES AND THE CANNULA HAS NEVER BEEN BENT BUT DID NOT CHANGE THE RESERVOIR. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534125 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAP A8723NAPJ

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention