BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2944821 · Received February 5, 2013

    Report

    Report Number
    3004209178-2013-90855
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 26, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE OF 22MG/DL WHEN HE ARRIVED IN THE HOSPITAL. IT WAS STATED THAT THE CUSTOMER WAS DISCONNECTED AT TIME OF HIS ADMISSION, AND THE INFUSION SET AND RESERVOIR WERE THROWN AWAY. TROUBLESHOOTING WAS PERFORMED. THE PRIMING TECHNIQUE WAS CORRECT, BUT THE PROGRAMMING REVEALED THAT THE CUSTOMER DID NOT BOLUS AT ALL THE DAY OF THE EVENT. IT WAS MENTIONED THAT THE DEVICE WAS NOT EXPOSED TO A HIGH MAGNETIC FIELD. ADVISED THE CALLER TO CALL BACK IF ISSUES PERSIST. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48570 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization