BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2912242 · Received January 11, 2013

    Report

    Report Number
    3004209178-2013-90227
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 27, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP RECEIVED WITH BLANK DISPLAY DUE TO MOISTURE DAMAGE ON ELECTRONIC ASSEMBLY. UNABLE TO VERIFY OCCLUSION TEST DUE TO BLANK DISPLAY.

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.MFG. REPORT 2 OF 2, MEDWATCH REPORT # 3004209178-2013-90227.MFG. REPORT 1 OF 2, MEDWATCH REPORT # 3004209178-2013-90226.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED EXPERIENCING UNEXPLAINED HIGH BLOOD GLUCOSE OF 260MG/DL. TROUBLESHOOTING WAS PERFORMED. ASSISTED THE CUSTOMER TO RUN THE HIGH PRESSURE TEST AND THE TEST FAILED TWICE. ADVISED THE CALLER THAT THE INSULIN PUMP WOULD BE REPLACED AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18304 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR