BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522NAS PRDGM INS V2.2 SK EN

    MDR report key: 1902339 · Received November 12, 2010

    Report

    Report Number
    3004209178-2010-83328
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 30, 2010
    Report Date
    November 1, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED FOR HIGH BLOOD GLUCOSE. THE CUSTOMER STATED THAT THE INSULIN PUMP DID NOT PRIME. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT SHE CHANGED THE INFUSION SET AND THE RESERVOIR PRIOR TO HER HOSPITALIZATION WHEN SHE NOTICED THAT HER GLUCOSE LEVEL WAS GOING UP AND IT DID NOT RESOLVE THE ISSUE. RAN A FIXED PRIME TEST AND THE INSULIN EXITED. THE TIME ON THE DEVICE WAS CORRECT. THE DAILY TOTALS DID NOT MATCH TO THE BOLUSES DONE FOR TWO DAYS. NO FURTHER INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization