BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522LWWS PRDGM INS SK EN LN

    MDR report key: 1211709 · Received October 23, 2008

    Report

    Report Number
    2032227-2008-01836
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    October 4, 2008
    Report Date
    October 8, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HYPERGLYCEMIA. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT INSULIN EXITED DURING THE PRIME TEST, BUT IT APPEARED LIKE THERE WAS LESS INSULIN THAN NORMAL. IT WAS REPORTED THAT THE CUSTOMER'S BLOOD GLUCOSE LEVELS DROPPED WHILE AT THE HOSPITAL, BUT WHEN THE CUSTOMER BEGAN USING THE INSULIN PUMP AGAIN, HER BLOOD GLUCOSE LEVELS DID NOT DROP. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization