BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3885216 · Received June 19, 2014

    Report

    Report Number
    3004209178-2014-86067
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 31, 2014
    Report Date
    June 7, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP RECEIVED WITH DETACHED END CAP. UNABLE TO PERFORM THE BASIC OCCLUSION AND OCCLUSION TEST DUE TO DETACHED END CAP. HOWEVER, DRIVE SUPPORT DISK WAS INSPECTED AND NO ANOMALY WAS NOTED. THE INSULIN PUMP HAD CRACKED DISPLAY WINDOW CORNERS, RESERVOIR TUBE LIP, SCRATCHED LCD WINDOW AND MISSING END CAP STICKER.

    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

    CUSTOMER STATED THAT SHE DROPPED THE PUMP A WEEK AGO AND THE DRIVE SUPPORT CAP SEEMS TO BE DAMAGED. CUSTOMER REPORTED THAT WHEN THE MOTOR REWINDS OR PRIMES THE WHOLE BACK END PUSHES OUT. CUSTOMER'S CURRENT BLOOD GLUCOSE IS 415 MG/DL. THE CUSTOMER STATED THAT THE CURRENT BLOOD GLUCOSE IS HIGH DUE TO OVER CORRECTING FOR A 53 MG/DL BLOOD GLUCOSE READING. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361061 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR