BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1063170 · Received June 20, 2008

    Report

    Report Number
    3004209178-2008-00436
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    June 10, 2008
    Report Date
    June 10, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 REPORTED HAVING LOW BLOOD GLUCOSE. THE BLOOD GLUCOSE READING WAS 47 MG/DL AT THE BEGINNING OF THE CALL. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING AND HISTORIES ON THE PUMP WERE ACCURATE. THE CUSTOMER STATED THAT SHE CHECKED HER BLOOD GLUCOSE SEVERAL TIMES AND THE GLUCOSE LEVEL WERE DROPPING. ADVISE CUSTOMER TO DRINK SOMETHING TO BRING UP HER BLOOD GLUCOSE WHILE PARAMEDICS ARE CALLED OUT.

    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 OPERATONS MED-REL MMT-522NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention