BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522NAB PRDGM INS V2.2 BL EN

    MDR report key: 1851631 · Received September 28, 2010

    Report

    Report Number
    3004209178-2010-82920
    Event Type
    Injury
    Date Received
    September 28, 2010
    Date of Event
    July 5, 2010
    Report Date
    September 13, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 REPORTED BEING HOSPITALIZED FOR LOW BLOOD GLUCOSE. THE BLOOD GLUCOSE READING AT TIME OF THE CALL WAS 169 MG/DL. THE CUSTOMER STATED THAT HER GLUCOSE LEVEL WAS LOWER THE DAY BEFORE HER ADMISSION. THE CUSTOMER STATED THAT SHE PASSED OUT AND WAS BROUGHT TO THE HOSPITAL. THE CUSTOMER ALSO STATED THAT SHE SUFFERED A HEART ATTACK DUE TO HER LOW GLUCOSE AND SHE WAS IN A COMA FOR FIVE TO SEVEN DAYS. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING AND HISTORIES WERE CORRECT. THE UNITS LEFT IN THE SCREEN WERE 15.4 UNITS AND THE UNITS LEFT IN THE RESERVOIR WERE APPROXIMATELY 20 U. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522NAB PRDGM INS V2.2 BL EN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization