BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2193310 · Received July 26, 2011

    Report

    Report Number
    3004209178-2011-82278
    Event Type
    Injury
    Date Received
    July 26, 2011
    Date of Event
    June 27, 2011
    Report Date
    July 11, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED DUE TO DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE OF 634MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER WAS EXPERIENCING UNEXPLAINED HIGH GLUCOSE FOR THE PAST DAYS. THE CUSTOMER STATED THAT THE MOST RECENT GLUCOSE READING WAS 24MG/DL IN THE MORNING, AND THE PARAMEDICS WERE CALLED. THEY TREATED HIM, AND HIS GLUCOSE LEVEL WENT UP TO 174MMG/DL. THE PROGRAMMING, TIME, AND DATE WERE CORRECT. THE CUSTOMER STATED THAT THE DIABETIC NURSE CHANGED THE BASAL RATES TWO MONTHS AGO. REVIEWED THE ALARM HISTORY AND FOUND SEVERAL MOTOR ERROR ALARMS DURING BASAL WITHIN THE PAST TWO WEEKS. ADVISED THE CUSTOMER THAT THE MOTOR ERROR ALARMS MAY HAVE CONTRIBUTED TO HIS LOW AND HIGH BLOOD GLUCOSE. RAN A DISPLACEMENT AND SELF TEST AND THE TESTS PASSED. REWIND AND MANUAL PRIME SUCCESSFULLY. ADVISED THE CUSTOMER TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization UNOMEDICAL INFUSION SET: MMT-399| QUICK-SET, 23, PARADIGM, 6MM CATHETER