BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522RNAB PRDGM INS BL EN RC

    MDR report key: 1031860 · Received April 16, 2008

    Report

    Report Number
    2032227-2008-00651
    Event Type
    Injury
    Date Received
    April 16, 2008
    Date of Event
    April 2, 2008
    Report Date
    April 2, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P98022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS STATED THAT THE CUSTOMER WAS HOSPITALIZED FOR LOW BLOOD GLUCOSE AND THE DR FELT THAT IT WAS RELATED TO THE BOLUS PROGRAMMING. NO BLOOD GLUCOSE READING WAS REPORTED. IT WAS STATED THAT THE CUSTOMER WOULD BE WORKING WITH THE DR TO ADJUST THE INSULIN PUMP SETTINGS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522RNAB PRDGM INS BL EN RC INFUSION PUMP LZG MEDTRONIC MINIMED MMT-522RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization