BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4142326 · Received October 5, 2014

    Report

    Report Number
    2032227-2014-33689
    Event Type
    Injury
    Date Received
    October 5, 2014
    Date of Event
    September 3, 2014
    Report Date
    October 14, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE FUNCTIONAL TEST, INCLUDING THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND EXCESSIVE NO DELIVERY TEST. THE INSULIN PUMP HAD A CRACKED CASE AT A DISPLAY WINDOW CORNER, A CRACKED RESERVOIR TUBE, A CRACKED RESERVOIR TUBE LIP, A CRACKED BELT CLIP SLOT AND MINOR SCRATCHES ON THE DISPLAY WINDOW. NO CRACK WAS NOTED ON THE DISPLAY WINDOW. NO DAMAGE WAS NOTED ON THE DISPLAY GLASS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN PROVIDED BY FAILURE ANALYSIS THAT WAS NOT INCLUDED ON THE INITIAL DEVICE EVALUATION: THE INSULIN PUMP PASSED THE DELIVERY VOLUME ACCURACY TEST.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP WAS CRACKED ON THE RESERVOIR COMPARTMENT AND DISPLAY SCREEN. CUSTOMER ALSO REPORTED THAT THE PARAMEDICS WERE RECENTLY CALLED TO RESPOND TO A LOS BLOOD GLUCOSE LEVEL OF 32 MG/DL. CUSTOMER REPORTED LOSING CONSCIOUSNESS AT THE TIME OF THIS EVENT, FALLING, AND BREAKING SEVERAL RIBS. BLOOD GLUCOSE LEVEL WAS 110 MG/DL AT THE TIME OF THE CALL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621916 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention