BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAH PRDGM INS PK

    MDR report key: 1781268 · Received July 28, 2010

    Report

    Report Number
    3004209178-2010-82192
    Event Type
    Injury
    Date Received
    July 28, 2010
    Date of Event
    July 8, 2010
    Report Date
    July 13, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE AND SLIGHT DIABETES KETOACIDOSIS. THE BLOOD GLUCOSE READING 760MG/DL. THE MOTHER STATED THAT THE INSULIN PUMP STARTED TO ALARM NO DELIVERY PRIOR TO THE EVENT. THE INFUSION SET WAS CHANGED WITHOUT ANY RESULTS. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING AND THE ALARM HISTORY WERE CORRECT. RAN A FIXED PRIME TEST AND PASSED. THE MOTHER ALSO STATED THAT THE CANNULAS SOMETIMES WERE BENT. PERFORMED TWICE THE HIGH PRESSURE TEST AND FAILED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAH PRDGM INS PK INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR