BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4131858 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-31502
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    August 30, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARM WAS NOTED DURING TESTING. THE INSULIN PUMP HAD A BROKEN RESERVOIR TUBE LIP, MISSING RESERVOIR O-RING, CRACKED RESERVOIR TUBE WINDOW, CRACKED CASE AT A DISPLAY WINDOW CORNER AND MINOR SCRATCHES ON THE DISPLAY WINDOW.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A BUTTON ERROR ON THE INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 121 MG/DL. CUSTOMER DOES NOT WANT TO TROUBLESHOOT FOR THE ACT BUTTON. CUSTOMER STATED THAT SHE PRESSED THE ACT BUTTON THREE TIMES AND THE PUMP DID NOT RESPOND. CUSTOMER STATED THAT THE TOP GROOVES ARE MISSING ON THE RESERVOIR ON THE RIGHT SIDE. CUSTOMER WAS ADVISED THAT THE PUMP WILL NEED TO BE REPLACED. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROFESSIONAL'S INSTRUCTION. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612045 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR