BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4111115 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-23051
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    June 24, 2014
    Report Date
    July 24, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    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.

    Description of Event or Problem · 1

    CUSTOMER STATED THAT EVERY TIME SHE CHANGES HER SET SHE RECEIVES A NO DELIVERY ALARM. CUSTOMER ALSO MENTIONED HAVING A CRACK ON THE FRONT OF THE INSULIN PUMP. CUSTOMER STATED THAT SHE TREATED BEFORE GOING TO SLEEP AND WOKE UP WITH BLOOD GLUCOSE READINGS OF 500 MG/DL. CUSTOMER FURTHER REPORTED THAT THE INSULIN PUMP RANDOMLY BEEPS THREE TIMES. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 103 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592552 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR