BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3051709 · Received April 10, 2013

    Report

    Report Number
    3004209178-2013-92499
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 28, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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 CALLED IN FROM WORK AND SHE WAS CONFUSED SINCE SHE HAD PUT ON HER INFUSION SET. THE CUSTOMER ATTEMPTED TO FILL THE TUBING SEVERAL TIMES. THE CALLER STATED THAT HER BLOOD GLUCOSE WAS 146MG/DL WHEN SHE STARTED THE PROCESS, BUT IT HAD DROPPED TO 70MG/DL. ADVISED THE CALLER TO DRINK ORANGE JUICE OR SOMETHING SHE MAY HAVE. WHILE SHE WAS ON THE PHONE THE PARAMEDICS WERE CALLED. THEY GAVE HER GRAPEFRUIT JUICE WITH SUGAR IN IT. THEN SHE ATE A TURKEY SANDWICH AND HER GLUCOSE LEVEL WENT UP TO 185MG/DL. THE CUSTOMER STATED THAT HER GLUCOSE LEVEL DROPPED TO 64MG/DL AND HER FINGERS WERE TINGLING. THE CUSTOMER STATED THAT SHE HAD A LOW RESERVOIR ALERT AND NO DELIVERY ALARMS. ADVISED TO REPLACE THE PLUNGER AND MANUALLY PUSH THE PLUNGER TO VERIFY THE INSULIN EXITS. ADVISED THE CALLER THAT THE INSULIN PUMP IS FUNCTIONING AS DESIGNED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148546 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention