BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-723RNAS PRDGM INS V2.3 SK EN RC

    MDR report key: 1812197 · Received August 20, 2010

    Report

    Report Number
    2032227-2010-82379
    Event Type
    Injury
    Date Received
    August 20, 2010
    Date of Event
    July 25, 2010
    Report Date
    July 26, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 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'S WIFE STATED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE LEVELS. DURING THE HOSPITALIZATION, THE INSULIN PUMP WAS EXPOSED TO AN X-RAY SCAN. THE WIFE STATED THAT THE CUSTOMER'S BLOOD GLUCOSE READING WAS 256 MG/DL WHEN HE WAS ADMITTED, BUT HE WAS FEELING SYMPTOMS OF LOW BLOOD GLUCOSE LEVELS. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE RESERVOIR VOLUME WAS CORRECT. ADVISED TO SPEAK WITH HIS DOCTOR TO MAKE SURE THAT HIS SETTINGS ARE CORRECT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-723RNAS PRDGM INS V2.3 SK EN RC INFUSION PUMP MDS MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization