BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2070269 · Received April 19, 2011

    Report

    Report Number
    3004209178-2011-81104
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 14, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UNABLE TO PRIME DURING THE PRIME TEST DUE TO THE FAULTY FORCE SENSOR. UNABLE TO PERFORM THE BASIC OCCLUSION, OCCLUSION AND EXCESSIVE NO DELIVERY TEST DUE TO THE PRIME/FILL ANOMALY. HOWEVER, THE INSULIN PUMP PASSED THE DISPLACEMENT TEST.

    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. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS, WITH A BLOOD GLUCOSE READING OF 439 MG/DL AND SYMPTOMS OF DIZZINESS, NAUSEA, VOMITING, AND EXCESSIVE URINATION. THE CUSTOMER STATED THAT SHE USES A QUICK-SET INFUSION SET AND THAT SHE SOMETIMES HAS BENT CANNULA. PROGRAMMING WAS CORRECT. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP PASSED BOTH THE FIXED PRIME AND THE HIGH PRESSURE TESTS. 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 PUERTO RICO OPERATIONS CO., JUNCOS MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization UNOMEDICAL QUICK-SET INSULIN INFUSION SET,| LOT 9202038