BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2190365 · Received July 28, 2011

    Report

    Report Number
    3004209178-2011-82331
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 14, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 THAT SHE WAS SEEKING A MEDICAL TREATMENT FOR CHEST PAINS. THE CUSTOMER HAD HIGH BLOOD GLUCOSE BEFORE SEEKING TREATMENT. THE CUSTOMER HAD A CONGESTIVE HEART FAILURE SEVERAL DAYS BEFORE AND HAD RECEIVED A DEFIBRILLATOR. THE CUSTOMER'S BLOOD GLUCOSE WAS 500MG/DL WHILE BEING AT THE HOSPITAL, AND SHE WAS NOT TREATED FOR HIGH GLUCOSE. THE CUSTOMER GAVE HERSELF A BOLUS OF 8.0 UNITS DURING THE CALL. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING, TIME, AND DATE ON THE INSULIN PUMP WERE CORRECT. RAN A FIXED PRIME TEST AND PASSED. THE CUSTOMER CHANGES THE INFUSION SET EVERY THREE TO FOUR DAYS. RECOMMENDED CUSTOMER TO CHANGE THE INFUSION SET EVERY TWO TO THREE DAYS. THE CUSTOMER'S GLUCOSE LEVEL STILL WAS READING HIGH ON THE BLOOD GLUCOSE METER. ADVISED THE CUSTOMER TO SEEK MEDICAL TREATMENT IF HER GLUCOSE LEVEL DOES NOT DROP. THE CUSTOMER CHANGED THE INFUSION SET AND RESERVOIR AND THE CANNULA WAS BENT. NO FURTHER INFO WAS PROVIDED.

    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 MED-REL MMT-522NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization UNOMEDICAL INFUSION SET: MMT-396| 9MM CATHETER| QUICK-SET PARADIGM 43"