BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-712LNAS PRDGM INS SK EN US LN

    MDR report key: 1912666 · Received November 24, 2010

    Report

    Report Number
    2032227-2010-83264
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 5, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO 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. AT THE TIME OF THE EVENT, THE CUSTOMER WAS VOMITING AND HAD TO HAVE HIS GALLBLADDER REMOVED. THE CUSTOMER'S BLOOD GLUCOSE READING WAS 574 MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE CUSTOMER USES SILHOUETTE INFUSION SETS. THE PRIME TEST PASSED. A TUBING CLAMP WAS NOT AVAILABLE TO PERFORM THE HIGH PRESSURE TEST. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-712LNAS PRDGM INS SK EN US LN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-712LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization