BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2800677 · Received October 22, 2012

    Report

    Report Number
    2032227-2012-07508
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Date of Event
    October 22, 2011
    Report Date
    October 22, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP ALARMED AN ERROR DURING THE BASIC OCCLUSION TEST AS A RESULT OF A LOOSE DRIVE SUPPORT DISK. THE DEVICE PASSED THE PRIME TEST. THE INSULIN PUMP HAD MISSING END CAP STICKER.

    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 REVERT TO BACK UP PLAN. THE CUSTOMER'S BLOOD GLUCOSE READING WAS 165MG/DL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP OYC OYC MEDTRONIC MINIMED MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR