BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4082294 · Received September 11, 2014

    Report

    Report Number
    2032227-2014-21378
    Event Type
    Malfunction
    Date Received
    September 11, 2014
    Date of Event
    August 9, 2014
    Report Date
    August 12, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP HAD MINOR SCRATCHES ON DISPLAY WINDOW NOTED DURING VISUAL INSPECTION. INSULIN PUMP HAD A CRACKED AND BLEEDING LCD GLASS NOTED.

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED FALLING DOWN AND BREAKING HIS INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE IS 121 MG/DL. THE DEVICE'S SCREEN IS BLANK AND BLEEDING. THE BUTTONS ARE UNRESPONSIVE. CUSTOMER DOES NOT THINK THE DEVICE IS DELIVERING INSULIN. CUSTOMER WAS ADVISED THE DEVICE NEEDS TO BE REPLACED, AND TO DISCONTINUE USE AND REVERT TO A BACK UP PLAN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562292 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR