BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1902332 · Received November 12, 2010

    Report

    Report Number
    3004209178-2010-83341
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 2, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING IN THE HOSP FOR A NON-RELATED DIABETES. HOWEVER, THE PROCEDURE DID NOT TAKE PLACE DUE TO CUSTOMER'S HIGH BLOOD GLUCOSE. THE CUSTOMER WAS TREATED WITH INSULIN DRIP. TROUBLESHOOTING WAS PERFORMED. THE ALARM HISTORY, DATE, AND TIME WERE CORRECT. THE CUSTOMER STATED THAT HER BLOOD GLUCOSE WAS HIGH FOR THE PAST TWO WEEKS. RAN A FIXED PRIME TEST AND THE INSULIN EXITED. PERFORMED A DISPLACEMENT TEST AND THE DEVICE ALARMED. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-715NAP PRDGM INS V2.1 PL EN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-715NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization