BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2072480 · Received April 21, 2011

    Report

    Report Number
    2032227-2011-00982
    Event Type
    Injury
    Date Received
    April 21, 2011
    Date of Event
    March 30, 2011
    Report Date
    April 7, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, 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 AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT HE WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE. CUSTOMER STATED THAT HE BLACKED OUT AT WORK AND HE HAD BLOOD IN HIS MOUTH. THE BLOOD GLUCOSE READING AT THE TIME HE WOKE UP WAS 213 MG/DL. CUSTOMER STATED THAT THE INSULIN PUMP HAD A CRACK CASE ON BOTH UPPER LEFT AND RIGHT CORNERS OF THE SCREEN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization