BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-715LNAS PRDGM INS V2.1 SK EN

    MDR report key: 1032390 · Received April 17, 2008

    Report

    Report Number
    2032227-2008-00653
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    April 2, 2008
    Report Date
    April 2, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HER DOCTOR WANTS THE INSULIN PUMP REPLACED BECAUSE IT NO LONGER HAS ANY AUDIBLE TONES. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP DID NOT BEEP DURING THE TONE TEST.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1