BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2234064 · Received August 29, 2011

    Report

    Report Number
    2032227-2011-02202
    Event Type
    Injury
    Date Received
    August 29, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 17, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. FURTHER INFORMATION 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 FAILED BATTERY TEST AND MOTOR ERROR ALARMS. THE CUSTOMER ALSO STATED THAT SHE WAS IN THE HOSPITAL DUE TO A STOMACH FLU A FEW DAYS AGO. THE CUSTOMER STATED THAT HER BLOOD GLUCOSE LEVELS WERE HIGH DURING THE HOSPITALIZATION. DURING THE CALL, THE CUSTOMER INSERTED A NEW BATTERY, AND THE SCREEN WAS BLANK. EARLIER, THE CUSTOMER HAD TROUBLE WITH THE INSULIN PUMP GOING TO THE REWIND SCREEN EVERY TIME THE ACT BUTTON WAS PRESSED. 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 INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-712LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization