BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-712NAS PRDGM INSULIN SK EN

    MDR report key: 1241038 · Received November 21, 2008

    Report

    Report Number
    2032227-2008-01982
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    November 6, 2008
    Report Date
    November 8, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, 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 PROD 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

    THE CUSTOMER STATED THAT HE WAS HOSPITALIZED DUE TO HYPERGLYCINEMIA. THE CUSTOMER REPORTED THAT HIS BLOOD GLUCOSE READING WAS ALMOST 1000 MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE PRIME AND HIGH PRESSURE TESTS PASSED. THE CUSTOMER STATED THAT A MONTH PRIOR TO THE EVENT AN ALARM HAD OCCURRED ON THE INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-712NAS PRDGM INSULIN SK EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-712NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization