BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2912245 · Received January 11, 2013

    Report

    Report Number
    3004209178-2013-90241
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 4, 2012
    Report Date
    December 28, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING IN THE EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE OF 550MG/DL. THE CUSTOMER MENTIONED THAT SHE CHANGED THE SITE LATE IN THE AFTERNOON AND HER BLOOD GLUCOSE WAS ABOUT 300MG/DL. THE CUSTOMER DID A CORRECTION AND A BOLUS. THEN MORE THAN AN HOUR LATER HER GLUCOSE WENT UP TO 450MG/DL. THE CUSTOMER ATTEMPTED TO DO A CORRECTION AGAIN, BUT THE INSULIN PUMP ALARMED MOTOR ERROR. REVIEWED THE ALARM HISTORY AND FOUND MORE THAN ONCE IN THE PAST MONTH. TROUBLESHOOTING WAS PERFORMED. THE DEVICE WAS NOT EXPOSED TO A HIGH MAGNETIC FIELD. THE DISPLACEMENT AND SELF TEST WERE PERFORMED AND PASSED. ADVISED THE CALLER THAT THE DEVICE 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
    18330 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization