BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4141186 · Received October 3, 2014

    Report

    Report Number
    2032227-2014-32781
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    PATIENT

    Narratives

    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).

    Additional Manufacturer Narrative · 1

    ALL OPERATING CURRENTS WERE WITHIN SPECIFICATION AND THE OFF NO POWER ALARM FUNCTIONED PROPERLY. NO BLANK DISPLAY WAS NOTED. NO DAMAGE WAS FOUND ON THE ISOLATION TAPE. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHES ON THE DISPLAY WINDOW, A SCRATCHED RESERVOIR TUBE WINDOW AND A STAINED END CAP STICKER.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THE INSULIN PUMP HAD A BLANK DISPLAY. BLOOD GLUCOSE READING WAS 77 MG/DL. THE BLANK DISPLAY ANOMALY OCCURRED WHEN THE CUSTOMER CHANGED THE BATTERY FOR THE INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED AND THE ISSUE COULD NOT BE RESOLVED. THE DISPLAY DID NOT RETURN. ADVISED THAT THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619657 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR