BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-715NAL PRDGM INS V2.1 CL EN

    MDR report key: 1092583 · Received August 1, 2008

    Report

    Report Number
    3004209178-2008-00576
    Event Type
    Injury
    Date Received
    August 1, 2008
    Date of Event
    July 21, 2008
    Report Date
    July 22, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED- REL
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. 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 HYPERGLYCEMIA. THE BLOOD GLUCOSE READING AT THE TIME OF THE EVENT WAS NOT REPORTED. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP FAILED THE PRIME TEST. THE CUSTOMER DID NOT HAVE THE NECESSARY SUPPLIES TO PERFORM ANY FURTHER TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-715NAL PRDGM INS V2.1 CL EN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED- REL MMT-715NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization