BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-512LNAP PRDGM INS PL EN US LN

    MDR report key: 1014016 · Received March 13, 2008

    Report

    Report Number
    2032227-2008-00479
    Event Type
    Malfunction
    Date Received
    March 13, 2008
    Date of Event
    February 18, 2008
    Report Date
    February 18, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD NO AUDIO TONE DUE TO A BROKEN TRANSDUCER WIRE ON THE INTERFACE BOARD. THE INSULIN PUMP HAD A NOISY MOTOR DURING THE REWIND. THE PROBLEM WAS ISOLATED TO THE MOTOR. NO ERROR ALARMS WERE NOTED.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER CALLED TO REPORT AN ERROR ALARM ON THE INSULIN PUMP. THE MOTHER THEN STATED THAT THE INSULIN PUMP NO LONGER HAS AUDIO TONES. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP DID NOT BEEP DURING THE TONE TEST. THE MOTHER ALSO REPORTED A BLOOD GLUCOSE READING OF 300 MG/DL, WHICH THE CUSTOMER TREATED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-512LNAP PRDGM INS PL EN US LN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-512LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1