BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4123669 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29813
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH NO BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARM DURING TESTING NOTED. THE INSULIN PUMP HAS CRACKED CASE AT DISPLAY WINDOW CORNERS, BATTERY TUBE THREADS, RESERVOIR TUBE LIP, BROKEN BELT CLIP SLOT, MINOR SCRATCHED AND CRACKED 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. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED A BUTTON ERROR ON HER INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE WAS 342 MG/DL. SHE WAS TRYING TO BOLUS FOR HER HIGH BLOOD GLUCOSE WHEN THE DEVICE ALARMED BUTTON ERROR. 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
    599977 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR