BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUP MMT-722LNAP PRDGM INS PL EN ML

    MDR report key: 1031555 · Received April 18, 2008

    Report

    Report Number
    2032227-2008-00669
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    April 5, 2008
    Report Date
    April 5, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 AS NO PRODUCT HAS BEEN RETURNED. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE WAS TREATED IN THE EMERGENCY ROOM FOR A HIGH BLOOD GLUCOSE READING OF 584 MG/DL. THE CUSTOMER STATED THAT HER BLOOD GLUCOSE LEVELS HAD BEEN HIGH SINCE THE NIGHT BEFORE THE EVENT. THE INSULIN PUMP WAS ALARMING DURING THE PHONE CALL. THE CUSTOMER WAS ASSISTED IN CLEARING THE ALARM AND PROGRAMMING THE CORRECT TIME AND DATE. THE BASAL RATES WERE REVIEWED AND THEY WERE CORRECT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUP MMT-722LNAP PRDGM INS PL EN ML INFUSION PUMP LZG MEDTRONIC MINIMED MMT-722LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention