BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 3110019 · Received May 13, 2013

    Report

    Report Number
    2032227-2013-01911
    Event Type
    Injury
    Date Received
    May 13, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    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. 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

    THE CUSTOMER REPORTED A MOTOR ERROR ALARM AFTER CHANGING THE INFUSION SET. THE REPORTED BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 378 MG/DL, AND WAS TREATED WITH A MANUAL INJECTION. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP FAILED THE DISPLACEMENT TEST. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210416 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR