BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3121154 · Received May 20, 2013

    Report

    Report Number
    3004209178-2013-93773
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 21, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP PASSED THE DISPLACEMENT TEST. THE DEVICE HAD A CRACKED CASE AT THE DISPLAY WINDOW CORNERS. THE UNIT WAS UNABLE TO PRIME DURING THE PRIME TEST AS A RESULT OF A PROTRUDED/LOOSE DRIVE SUPPORT DISK. FURTHER TESTING COULD NOT BE PERFORMED DUE TO THE PRIME/FILL ANOMALY. THE MOTOR PASSED THE MOTOR TEST.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP WAS NOT PRIMING CORRECTLY, AND INSULIN SQUIRTED OUT. THE BLOOD GLUCOSE READING WAS 113MG/DL. TROUBLESHOOTING WAS PERFORMED. THE DRIVE SUPPORT CAP WAS SLIGHTLY STICKING OUT AND TILTED. THE DISPLAY WINDOW WAS ALSO CRACKED. ADVISED THE CALLER TO DISCONTINUE THE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221501 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR