BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-515NAS PRDGM INS V2.1 SK EN

    MDR report key: 1060347 · Received June 13, 2008

    Report

    Report Number
    2032227-2008-00985
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    May 29, 2008
    Report Date
    May 31, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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 STATED SHE WAS HOSPITALIZED DUE TO HYPERGLYCEMIA. THE REPORTED BLOOD GLUCOSE READING WAS "HIGH." TROUBLESHOOTING WAS PERFORMED AND THE PROGRAMMING WAS CORRECT. THE INSULIN PUMP PASSED THE PRIME TEST. THE CUSTOMER DID NOT HAVE A TUBING CLAMP TO PERFORM THE HIGH PRESSURE TEST, SO A TUBING CLAMP WAS SENT TO HER. THE CUSTOMER WAS ADVISED OF THE TWO HIGH BLOOD SUGAR RULE AND TO CONSULT WITH THEIR DOCTOR ABOUT A BACKUP PLAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-515NAS PRDGM INS V2.1 SK EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-515NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization