BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QPARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2243578 · Received September 2, 2011

    Report

    Report Number
    3004209178-2011-82841
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    August 23, 2011
    Report Date
    August 23, 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 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 BEING HOSPITALIZED FOR HIGH BLOOD GLUCOSE OF 438 MG/DL. TROUBLESHOOTING WAS PERFORMED. ALL THE PROGRAMMING WAS CORRECT WITH NO MALFUNCTION ALARMS ON THE ALARM HISTORY. RAN A FIXED PRIME AND THE TEST PASSED. A TUBING CLAMP WILL BE SENT TO THE CUSTOMER TO COMPLETE TESTING. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QPARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization NOMEDICAL INFUSION SET, MMT-397| QUICK-SET, 23| PARADIGM, 9 MM CATHETER