BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522NAL PRDGM INS V2.2 CL EN

    MDR report key: 1063306 · Received June 19, 2008

    Report

    Report Number
    2032227-2008-01025
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    June 7, 2008
    Report Date
    June 7, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, 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 BEING ADMITTED IN THE EMERGENCY ROOM FOR LOW BLOOD GLUCOSE. THE BLOOD GLUCOSE READING WAS 110MG/DL. THE CUSTOMER STATED THAT HIS BLOOD GLUCOSE WAS HIGH AND TREATED WITH 7U. THE CUSTOMER STATED THAT HE TREATED HIS BLOOD GLUCOSE BASED ON THE SENSOR VALUE AND HE DID NOT EAT ALL THAT HE HAD BOLUSED FOR. TROUBLESHOOTING WAS PERFORMED. THE ALARM HISTORY DID NOT RECALL ANY ALARMS AND THE SELF-TEST WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522NAL PRDGM INS V2.2 CL EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-522NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization