BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3160721 · Received June 10, 2013

    Report

    Report Number
    3004209178-2013-94595
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    May 25, 2013
    Report Date
    May 25, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 IN THE EMERGENCY ROOM DUE TO DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE OVER 600MG/DL. THE CALLER STATED THAT HER GLUCOSE LEVEL WENT FOR 85 TO OVER 600MG/DL IN FORTY FIVE MINUTES. THE CUSTOMER MENTIONED HAVING A DIABETES KETOACIDOSIS EVERY MONTH, BUT SHE HAS NOT BEEN HOSPITALIZED EACH TIME. TROUBLESHOOTING WAS PERFORMED. PERFORMED THE SELF TEST AND PASSED. INITIALLY, THE CUSTOMER REPORTED THAT HER INSULIN PUMP HAD A BLANK DISPLAY. ADVISED THE CUSTOMER TO REMOVE THE BATTERY FOR TEN MINUTES AND REVERT TO BACK UP PLAN. REVIEWED THE ALARM HISTORY AND FOUND AN ERROR ALARMS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261117 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 11 YR Hospitalization