BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4161904 · Received October 10, 2014

    Report

    Report Number
    2032227-2014-36093
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 11, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH A DETACHED END CAP, MINOR SCRATCHES ON THE DISPLAY WINDOW, A BROKEN RESERVOIR TUBE LIP, AND CRACKED BATTERY TUBE THREADS. NO MOTOR ERROR ALARM COULD BE VERIFIED DUE TO THE DETACHED END CAP. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED. NO MOTOR ERROR ALARM WAS 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

    CUSOTMER REPORTED THAT THE BOTTOM PART OF HER INSULIN PUMP HAD FALLEN OFF. SHE STATED THE DAMAGE WAS CAUSED BY HER TAKING OFF HER BELT CLIP. CUSTOMER'S BLOOD GLUCOSE WAS 509 MG/DL. THE CUSTOMER HAD TREATED HER BLOOD GLUCOSE WITH THE INSULIN PUMP. SHE ALSO STATED THE BOTTOM PART OF HER INSULIN PUMP WOULD NOT STAY ON WITHOUT THE BELT CLIP. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644095 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR