BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522LNAL PRDGM INS CL EN ML

    MDR report key: 1002508 · Received February 26, 2008

    Report

    Report Number
    2032227-2008-00391
    Event Type
    Injury
    Date Received
    February 26, 2008
    Date of Event
    February 13, 2008
    Report Date
    February 14, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    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. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HE WAS TREATED BY THE PARAMEDICS FOR A LOW BLOOD GLUCOSE READING OF 35 MG/DL. THE CUSTOMER CHANGED THE INFUSION SET THE DAY PRIOR TO THE EVENT. THE CUSTOMER STATED THAT THE INSULIN PUMP GAVE HIM TWO WARNINGS THAT HIS BLOOD GLUCOSE LEVELS WERE DROPPING. THE CUSTOMER STATED HE TREATED HIS BLOOD GLUCOSE AFTER HE RECEIVED THE FIRST WARNING, PRIOR TO THE ARRIVAL OF THE PARAMEDICS. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention