BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2834497 · Received November 15, 2012

    Report

    Report Number
    3004209178-2012-90787
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    November 4, 2012
    Report Date
    November 4, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    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. MFG. REPORT 1 OF 3, MEDWATCH REPORT # 3004209178-2012-90787, MFG. REPORT 2 OF 3, MEDWATCH REPORT # 3004209178-2012-90795, MFG. REPORT 3 OF 3, MEDWATCH REPORT # 3004209178-2012-90802.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING AN URGENT CARE VISIT DUE TO HIGH BLOOD GLUCOSE OF 327MG/DL. THE CUSTOMER EXPERIENCED FRUITY BREATH, ABDOMINAL PAIN, NAUSEA, FATIGUE, AND EXCESSIVE THIRST. THE CUSTOMER MENTIONED THAT THE INSULIN PUMP WAS NOT DELIVERING INSULIN PROPERLY. TROUBLESHOOTING WAS PERFORMED. THE TIME AND DATE WERE INCORRECT. ASSISTED THE CUSTOMER TO CORRECT THEM. AFTER RECEIVING THE TUBING CLAMP THE CUSTOMER CALLED BACK TO PERFORM THE HIGH PRESSURE TEST AND PASSED. INSTRUCTED THE CUSTOMER TO REMOVE THE CANNULA AND IT WAS NOT BENT OR OCCLUDED. ADVISED THE CUSTOMER TO CHANGE THE ENTIRE INFUSION SET AND RESERVOIR. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization