BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522NAL PRDGM INS V2.2 CL EN

    MDR report key: 925602 · Received October 11, 2007

    Report

    Report Number
    3004209178-2007-00484
    Event Type
    Injury
    Date Received
    October 11, 2007
    Date of Event
    April 16, 2007
    Report Date
    April 24, 2007
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    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. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS STATED THAT THE CUSTOMER GAVE A SMALL BOLUS AND EXPERIENCED VERY LOW BLOOD GLUCOSE. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP PASSED THE DISPLACEMENT TEST. THE CUSTOMER LATER CALLED AND STATED THAT HE WAS HOSPITALIZED FOR LOW BLOOD GLUCOSE. PRIOR TO THE HOSPITALIZATION, THE CUSTOMER STATED HE WOKE UP WITH A BLOOD GLUCOSE READING OF 239 MG/DL. THE CUSTOMER STATED THAT HE TREATED THE GLUCOSE AND WITHIN THIRTY MINS HIS BLOOD GLUCOSE READING WAS 30 MG/DL. THE CUSTOMER STATED HE WS NOT PRIMING OR REWINDING AND HE HAD NOT CHANGED ANY OF THE SETTINGS ON THE INSULIN PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522NAL PRDGM INS V2.2 CL EN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization