BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2170688 · Received July 12, 2011

    Report

    Report Number
    3004209178-2011-82148
    Event Type
    Injury
    Date Received
    July 12, 2011
    Date of Event
    June 29, 2011
    Report Date
    June 29, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 DUE TO HIGH BLOOD GLUCOSE OF 422MG/DL. THE EVENTS LEADING TO HER ADMISSION WERE CONFUSION, FATIGUE, AND VOMITING. THE CUSTOMER WAS EXPERIENCING HIGH GLUCOSE FOR THE PAST WEEK. THE CUSTOMER'S MOST RECENT GLUCOSE READING WAS 212MG/DL AND WAS TREATED WITH THE INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING, TIME, AND DATE WERE CORRECT. RAN A FIXED PRIME AND PASSED. DURING THE CALL, THE CUSTOMER ALSO MENTIONED THAT SHE HAS BEEN BOTTOMING OUT AS WELL. THE CUSTOMER STATED THAT SHE HAD LOW BLOOD GLUCOSE IN THE PAST, AND SHE HAS TREATED WITH GLUCOSE TABLETS. THE CUSTOMER STATED THAT THERE IS MORE INSULIN IN THE STATUS SCREEN THAN THE RESERVOIR. ALSO, IT WAS FOUND THAT THE CUSTOMER HAS BEEN OVER BOLUSING AND THE BASALS WERE CHANGED TO CORRECT HER HIGH BLOOD GLUCOSE. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS EXPOSED TO AN MRI. RAN A DISPLACEMENT AND HIGH PRESSURE TEST AND THE TESTS PASSED. 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-522NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization SILHOUETTE 23"| (B)(4) INFUSION SET: MMT-381