BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522RNAB PRDGM INS BL EN RC

    MDR report key: 1870112 · Received October 11, 2010

    Report

    Report Number
    2032227-2010-82900
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 22, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS, WITH A READING A 540 MG/DL. PRIOR TO THE EVENT, THE CUSTOMER WOKE UP WITH BLOOD GLUCOSE LEVELS ABOVE 600 MG/DL, AND WAS VOMITING. THE INSULIN PUMP WAS ALSO ALARMING NO DELIVERY. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE CALLER WAS UNABLE TO CONDUCT THE PRIME TEST AT THE TIME OF THE CALL, AND STATED SHE WOULD CALL BACK. 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 25 YR Hospitalization