BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2914578 · Received January 14, 2013

    Report

    Report Number
    3004209178-2013-90267
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 28, 2012
    Report Date
    December 29, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING ADMITTED AS AN INPATIENT FOR MEDICAL TREATMENT WITH HER LOW BLOOD GLUCOSE OF 50MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT SHE FELL CONFUSED WITH THE NEW MENU FOR PRIMING, AND HER DOCTOR TOLD HER TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO BACK UP PLAN. THE RESERVOIR WAS SHOWING LESS INSULIN THAN WHAT IS SHOWING ON THE STATUS SCREEN. ASSISTED THE CALLER TO RUN THE DISPLACEMENT TEST AND PASSED. REVIEWED THE BOLUS HISTORY AND FOUND THAT THE CUSTOMER DID FILL THE CANNULA AND THEN TWO FILL TUBINGS ONE FOR 30.40 UNITS WHICH IS A LOT MORE THAN IT USUALLY TAKES. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21039 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization