BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522LNAL

    MDR report key: 1962794 · Received January 11, 2011

    Report

    Report Number
    2032227-2011-00083
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    December 23, 2010
    Report Date
    December 24, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 REPORTED THAT HE WAS HOSPITALIZED FOR LOW BLOOD GLUCOSE LEVELS, WITH A READING OF 15 MG/DL. PRIOR TO THE EVENT, THE CUSTOMER WAS WAITING TO OPEN THE CAR DOOR FOR HIS WIFE. SHE SAW THAT HE WAS NOT RESPONDING, AND THE PARAMEDICS WERE CALLED. THE CUSTOMER COULD NOT RECALL ANYTHING ELSE AS HE LOST CONSCIOUSNESS. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE SELF TEST. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522LNAL PARADIGM REAL-TIME INSULIN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-522LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization