BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 1992943 · Received February 7, 2011

    Report

    Report Number
    3004209178-2011-80344
    Event Type
    Injury
    Date Received
    February 7, 2011
    Date of Event
    January 27, 2011
    Report Date
    January 27, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED FOR DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE OF 414 MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT SHE HAD LOW BLOOD GLUCOSE PRIOR TO HER ADMISSION. THE CUSTOMER STATED THAT SHE HAS TREATED WITH A MANUAL INJECTION. REVIEWED THE PROGRAMMING ON THE INSULIN PUMP. THE CUSTOMER STATED THAT SHE DOES NOT FEEL COMFORTABLE WITH THE DEVICE AND A REPLACEMENT OF THE DEVICE WAS REQUESTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization