BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 4230778 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48245
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    September 24, 2014
    Report Date
    October 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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

    CUSTOMER REPORTED THAT THE INSULIN PUMP HAS BEEN GETTING STUCK ON THE PREPARING TO PRIME LOOP FOR ABOUT 2 WEEKS. CUSTOMER WAS ADVISED TO HOLD DOWN THE ACT BUTTON UNTIL RECEIVING A SECOND SERIES OF BEEPS OR NUMBERS APPEAR ON THE DISPLAY. CUSTOMER DID NOT RECEIVE ANY BEEPS OR NUMBERS. CUSTOMER WAS ADVISED THAT THE INSULIN PUMP HAD TO BE REPLACED. BLOOD GLUCOSE VALUE WAS 119 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715015 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-512NAS 44009

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR