BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NALCL PRDGM INS CL EN C

    MDR report key: 1103183 · Received August 8, 2008

    Report

    Report Number
    2032227-2008-01365
    Event Type
    Injury
    Date Received
    August 8, 2008
    Date of Event
    July 28, 2008
    Report Date
    July 29, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 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

    IT WAS REPORTED THAT THE CUSTOMER WAS FOUND UNRESPONSIVE AND FROTHING AT THE MOUTH. IT WAS REPORTED THAT THE CUSTOMER'S BLOOD GLUCOSE WAS CHECKED, AND THE READING WAS 51 MG/DL. IT WAS REPORTED THAT THE CUSTOMER WAS THEN TREATED BY PARAMEDICS AND TAKEN TO THE HOSPITAL. IT WAS ALSO REPORTED THAT ADJUSTMENTS WERE MADE TO THE CUSTOMER'S BASAL AND BOLUS RATES. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NALCL PRDGM INS CL EN C INFUSION PUMP LZG MEDTRONIC MINIMED MMT-722NALCL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization