BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522LNAL PRDGM INS CL EN ML

    MDR report key: 1050165 · Received May 23, 2008

    Report

    Report Number
    2032227-2008-00885
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    May 12, 2008
    Report Date
    May 13, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY CALLED TO REPORT SEVERAL FAILED BATTERY TEST ALARMS. THE CUSTOMER THEN STATED THAT HE WAS TREATED BY THE PARAMEDICS DUE TO LOW BLOOD GLUCOSE LEVELS. NO BLOOD GLUCOSE READING WAS REPORTED FOR THE EVENT. THE CUSTOMER HAD TO GO TO WORK AND WAS UNABLE TO TROUBLESHOOT. FOUND THAT THE CUSTOMER HAS ONLY BEEN ON INSULIN PUMP THERAPY FOR ONE WEEK AND HAD A FEW BASAL RATES PROGRAMMED IN THE INSULIN PUMP THAT HE WAS NOT AWARE OF. THE CUSTOMER ALSO STATED THAT THE SCREEN WENT BLANK LAST NIGHT. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED, BUT TO SPEAK TO HIS DR ABOUT GETTING BASAL RATES PROGRAMMED CORRECTLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention