BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REA-TIME INSULIN INFUSION PUMP

    MDR report key: 2417556 · Received January 9, 2012

    Report

    Report Number
    3004209178-2012-84520
    Event Type
    Injury
    Date Received
    January 9, 2012
    Date of Event
    December 16, 2011
    Report Date
    December 19, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE OF 790MG/DL. THE CUSTOMER WAS EXPERIENCING UNEXPLAINED HIGH GLUCOSE FOR TWO DAYS. TROUBLESHOOTING WAS PERFORMED. THE EVENTS LEADING TO HIS ADMISSION WAS VOMITING AND WAS NOT BEING ABLE TO KEEP WATER DOWN. THE PROGRAMMING, TIME, AND DATE WERE CORRECT. REVIEWED THE ALARM HISTORY AND FOUND LOW RESERVOIR ALARMS. THE CUSTOMER STATED THAT THE INFUSION SET WAS CHANGED TO RESOLVE THE ISSUE. RAN A FIXED PRIME AND HIGH PRESSURE TEST AND THEY PASSED. DURING THE CALL WAS FOUND THAT THE CUSTOMER WAS USING THE INFUSION SETS FOR FIVE DAYS. THE CUSTOMER STATED THAT HE SMELLS INSULIN IN THE RESERVOIR COMPARTMENT, AND THERE ARE CRACKS AND DAMAGES TO THE INSULIN PUMP. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WILL BE REPLACED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REA-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization UNOMEDICAL INFUSION SET