BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2232611 · Received August 25, 2011

    Report

    Report Number
    2032227-2011-02170
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 14, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE WAS HOSPITALIZED WITH A LOW BLOOD GLUCOSE READING OF 42 MG/DL. THE CUSTOMER STATED THAT HE CHANGED THE INFUSION SET JUST BEFORE GOING TO BED THAT NIGHT. THE CUSTOMER WOKE UP, THEN COLLAPSED. THE CUSTOMER ALSO REPORTED PROBLEMS WITH THE BUTTONS NOT RESPONDING. TROUBLESHOOTING WAS NOT POSSIBLE DUE OT THE UNRESPONSIVE BUTTONS. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization