BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522PNAL PRDGM INS CL EN PW

    MDR report key: 1142774 · Received August 27, 2008

    Report

    Report Number
    2032227-2008-01482
    Event Type
    Injury
    Date Received
    August 27, 2008
    Date of Event
    July 28, 2008
    Report Date
    August 20, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE WAS TREATED BY PARAMEDICS DUE TO HYPOGLYCEMIA. THE CUSTOMER STATED THAT IT IS NORMAL FOR HER TO HAVE HYPOGLYCEMIA EPISODES, BUT SHE IS USUALLY ABLE TO TREAT THE LOW BLOOD GLUCOSE LEVELS WITHOUT REQUIRING MEDICAL INTERVENTION. THE CUSTOMER DECLINED TO PERFORM TROUBLESHOOTING ON THE INSULIN PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522PNAL PRDGM INS CL EN PW INFUSION PUMP LZG MEDTRONIC MINIMED MMT-522PNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention