BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1052824 · Received May 27, 2008

    Report

    Report Number
    2032227-2008-00893
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    May 14, 2008
    Report Date
    May 14, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP FUNCTIONED PROPERLY DURING THE REWIND, BASIC OCCLUSION, PRIME, EXCESSIVE NO DELIVERY AND DISPLACEMENT TESTS. THE INSULIN PUMP HAD NO BACK LIGHT DUE TO A FAULTY COMPONENT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE WAS TREATED IN THE ER ROOM FOR HIGH BLOOD GLUCOSE LEVELS. NO BLOOD GLUCOSE READING WAS REPORTED. THE CUSTOMER STATED THAT SHE EXPERIENCED HIGH BLOOD GLUCOSE LEVELS FOR THE PAST TWO DAYS. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME TEST, BUT THE CUSTOMER DID NOT HAVE THE TUBING CLAMP TO PERFORM THE HIGH PRESSURE TEST. THE CUSTOMER ALSO STATED THAT THE BACK LIGHT NO LONGER WORKS. THE CUSTOMER AND HER DR BOTH FELT THAT THE INSULIN PUMP SHOULD BE REPLACED. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED PER HER DR'S RECOMMENDATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization