BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522LNAS PRDGM INS SK EN ML

    MDR report key: 1780308 · Received July 26, 2010

    Report

    Report Number
    2032227-2010-81993
    Event Type
    Injury
    Date Received
    July 26, 2010
    Date of Event
    July 7, 2010
    Report Date
    July 7, 2010
    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 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 HAVING HIGH BLOOD PRESSURE. TROUBLESHOOTING WAS PERFORMED. THE SETTINGS WERE CORRECT AND THE ALARM HISTORY DID NOT REVEAL ANY ALARM. THE AMOUNT OF INSULIN LEFT IN THE RESERVOIR MATCHED TO THE AMOUNT OF INSULIN ON THE DISPLAY. RAN A FIXED PRIME TEST AND PASSED. DURING THE CALL, THE CUSTOMER MENTIONED BEING IN THE HOSPITAL FOR A SKIN INFECTION. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522LNAS PRDGM INS SK EN ML INFUSION PUMP LZG MEDTRONIC MINIMED MMT-522LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization