BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-723NAB PRDGM INSULIN BLUE EN

    MDR report key: 1853356 · Received October 1, 2010

    Report

    Report Number
    3004209178-2010-82976
    Event Type
    Injury
    Date Received
    October 1, 2010
    Date of Event
    August 31, 2010
    Report Date
    September 19, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 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 FOR HIGH BLOOD GLUCOSE CAUSING MIGRAINE HEADACHES. THE BLOOD GLUCOSE READING WAS 279MG/DL. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING AND THE DAILY TOTALS MATCH THE BOLUS PLUS THE BASAL AND TIMES. THE ALARM HISTORY REVEALED SEVERAL LOW RESERVOIR ALARMS. RAN A FIXED PRIME TEST AND THE INSULIN EXITED. THE CUSTOMER STATED THAT WHEN HE INSERTS THE INFUSION SET IN HIS ARM, THE INSULIN IS POOLING UNDER THE SKIN. ADVISED THE CUSTOMER TO CONTACT HIS DOCTOR TO FIND WHAT OTHER SITES HE COULD USE. PERFORMED A HIGH PRESSURE TEST AND THE DEVICE PASSED THE TEST. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-723NAB PRDGM INSULIN BLUE EN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization