BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522RNAB PRDGM INS BL EN RC

    MDR report key: 1780972 · Received July 27, 2010

    Report

    Report Number
    2032227-2010-82030
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    July 3, 2010
    Report Date
    July 5, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 HE WAS HOSPITALIZED FOR LOW BLOOD GLUCOSE LEVELS. THE REPORTED BLOOD GLUCOSE READING WAS 20 MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE RESERVOIR VOLUME MATCHED THE AMOUNT OF INSULIN IN THE RESERVOIR. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522RNAB PRDGM INS BL EN RC INFUSION PUMP MDS MEDTRONIC MINIMED MMT-522RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization