BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3120971 · Received May 20, 2013

    Report

    Report Number
    2032227-2013-02005
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 25, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS
    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

    THE CUSTOMER STATED THAT HE WAS HOSPITALIZED WITH A BLOOD GLUCOSE OF 555 MG/DL. THE CUSTOMER STATED THAT HE HAD BEEN EXPERIENCING HIGH BLOOD GLUCOSE LEVELS FOR THREE TO FOUR DAYS PRIOR TO THE EVENT. THE CUSTOMER HAD BEEN TREATED WITH THE INSULIN PUMP, BUT CONTINUED TO EXPERIENCE HIGH BLOOD GLUCOSE LEVELS, AND FINALLY DECIDED TO GO TO THE HOSPITAL. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP PROGRAMMED CORRECTLY EXCEPT FOR THE TIME AND DATE. ASSISTED WITH THE PROGRAMMING. THE INSULIN PUMP PASSED THE PRIME TEST, BUT THERE WAS NO TUBING CLAMP FOR THE HIGH PRESSURE TEST. SENT A TUBING CLAMP TO THE CUSTOMER. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222228 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization