BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2863225 · Received December 10, 2012

    Report

    Report Number
    3004209178-2012-91136
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    October 22, 2012
    Report Date
    November 28, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS UNABLE TO PRIME DURING THE PRIME TEST AS A RESULT OF A LOOSE DRIVE SUPPORT DISK. THE MOTOR WAS TESTED AND PASSED THE TEST. THE DEVICE HAD MISSING END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP ALARMED MOTOR ERROR SEVERAL TIMES DURING BASAL DELIVERY. THE BLOOD GLUCOSE READING WAS 156MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CALLER STATED THAT THE DEVICE WAS NOT EXPOSED TO A HIGH MAGNETIC FIELD. ASSISTED THE MOTHER TO RUN THE DISPLACEMENT AND SELF TEST AND THEY PASSED. 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 PUERTO RICO OPERATIONS CO. MMT-722NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR