BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3894842 · Received June 25, 2014

    Report

    Report Number
    2032227-2014-03372
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PATIENT

    Narratives

    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 HAD AN ACCIDENT 5 YEARS AGO BECAUSE OF A RECALL ON HER INFUSION SETS. THE CUSTOMER STATED THAT SHE PASSED OUT THREE TIMES ON THE TABLE BECAUSE THE INFUSION SET GAVE HER INSULIN WHEN IT WAS NOT SUPPOSED TO. THE BLOOD GLUCOSE LEVEL AT THE TIME OF HOSPITALIZATION WAS UNKNOWN. THE CUSTOMER CALLED TO VERIFY WHETHER THERE IS A RECALL ON HER CURRENT INFUSION SETS. SHE REPORTED THAT HER BLOOD GLUCOSE WAS 65 MG/DL, AND SHE TREATED BY CONSUMING TWO FRUITS AND A SODA. THE BLOOD GLUCOSE READING WAS 139 MG/DL AT THE TIME OF THE CALL. THE CUSTOMER DECLINED TROUBLESHOOTING. ADVISED CUSTOMER THAT THERE WAS NO RECALL ON HER INFUSION SETS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370492 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization