BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MTT-715NAP PRDGM INS V2.1 PL EN

    MDR report key: 1180056 · Received September 26, 2008

    Report

    Report Number
    2032227-2008-01673
    Event Type
    Injury
    Date Received
    September 26, 2008
    Date of Event
    September 16, 2008
    Report Date
    September 16, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 FOR HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING AT TIME OF THE CALL WAS 267MG/DL. THE CUSTOMER WOKE UP FEELING ILL AND THE INSULIN PUMP ALARMED NO DELIVERY. THE INFUSION SET WAS CHANGED AND THE CUSTOMER WENT TO BED. THE CUSTOMER WOKE UP ILL AGAIN AND THE PARAMEDICS WERE CALLED. LATER, THE CUSTOMER WAS ADMITTED IN THE EMERGENCY ROOM. TROUBLESHOOTING WAS PERFORMED. WHILE TRYING TO PRIME THE INSULIN PUMP ALARMED NO DELIVERY, INSULIN SQUIRTED OUT, AND THEN GAVE DIFFERENT ALARM. ADVISED CUSTOMER TO DISCONTINUE THE INSULIN PUMP USED AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MTT-715NAP PRDGM INS V2.1 PL EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization