BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 3222975 · Received July 12, 2013

    Report

    Report Number
    2032227-2013-02882
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 18, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K001829
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS, WITH A BLOOD GLUCOSE OF 488 MG/DL. IT WAS STATED THAT THE CUSTOMER WAS GETTING MOTOR ERROR ALARMS, AND THE ACT BUTTON WAS NOT RESPONDING. PRIOR TO THE EVENT, THE CUSTOMER WAS AT WORK, AND WAS NOT FEELING WELL. THE CUSTOMER TREATED WITH A BOLUS AND A MANUAL INJECTION, BUT HER BLOOD GLUCOSE LEVELS CONTINUED TO ELEVATE. THE CUSTOMER CALLED HER HCP, AND WAS TOLD TO GO TO THE HOSPITAL. HAD THE CALLER INSPECT THE DRIVE SUPPORT CAP, AND IT WAS LOOSE. ADVISED THE CALLER THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324144 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-511LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization