BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522RNAB PRDGM INS BL EN RC

    MDR report key: 1111034 · Received August 12, 2008

    Report

    Report Number
    2032227-2008-01375
    Event Type
    Injury
    Date Received
    August 12, 2008
    Date of Event
    July 30, 2008
    Report Date
    July 30, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 PROD 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 COMPLAINED OF LOW BLOOD GLUCOSE LEVELS. THE REPORTED BLOOD GLUCOSE READING WAS 58 MG/DL. DURING THE PHONE CALL, THE CUSTOMER'S BLOOD GLUCOSE LEVELS CONTINUED TO DROP. THE CUSTOMER WAS ADVISED TO DRINK ORANGE JUICE TO TREAT THE LOW BLOOD GLUCOSE, AND PARAMEDICS WERE CALLED TO THE SCENE. AFTER THE PARAMEDICS ARRIVED, THE CUSTOMER WAS ADVISED TO REVERT TO A BACKUP PLAN UNTIL TROUBLESHOOTING COULD BE PERFORMED ON THE INSULIN PUMP. THE CUSTOMER CALLED BACK TO PERFORM TROUBLESHOOTING, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE CUSTOMER STATED THAT PRIOR TO THE EVENT HE HAD JUST SWITCHED INSULIN FROM HUMALOG TO NOVOLOG. THE CUSTOMER WAS ADVISED TO DISCUSS THE LOW BLOOD GLUCOSE LEVELS WITH HIS DOCTOR.

    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 Required Intervention