BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2791847 · Received October 15, 2012

    Report

    Report Number
    2032227-2012-07420
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    September 4, 2012
    Report Date
    October 4, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP ALARMED AN ERROR DURING THE PRIME TEST AS A RESULT OF A LOOSE DRIVE SUPPORT DISK.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP HAD AN ERROR ALARM DURING THE MANUAL PRIME PROCESS. ADVISED THE CUSTOMER TO REVERT TO BACK UP PLAN. THE CUSTOMER'S BLOOD GLUCOSE READING WAS 126MG/DL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR