BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4193027 · Received October 22, 2014

    Report

    Report Number
    2032227-2014-41771
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    August 23, 2014
    Report Date
    September 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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

    (B)(4).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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO DISPLAY ANOMALY WAS NOTED. THE INSULIN PUMP COMMUNICATED PROPERLY WITH THE TEST GLUCOSE SENSOR SIMULATOR. NO RADIO FREQUENCY ANOMALY WAS NOTED. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW, CRACKED RESERVOIR TUBE LIP, CRACKED BELT CLIP SLOT AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A BUTTON ERROR ALARM ON THE INSULIN PUMP. CUSTOMER WAS TRYING TO PUT THE NUMBERS IN FOR THE GRAMS, BUT THE NUMBERS KEPT SCROLLING. CUSTOMER STATED THAT SHE HAD TROUBLE CONNECTING THE METER AND SHE ALSO HAD ISSUES WITH THE BUTTONS. INSULIN PUMP WILL NEED TO BE REPLACED DUE TO THE ISSUES WITH THE BUTTONS. CUSTOMER WAS ADVISED THAT WHEN THE REPLACEMENT PUMP ARRIVES, SHE WILL BE ASSISTED IN PROGRAMMING. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671988 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR