BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2884404 · Received December 22, 2012

    Report

    Report Number
    3004209178-2012-91546
    Event Type
    Malfunction
    Date Received
    December 22, 2012
    Date of Event
    September 21, 2012
    Report Date
    December 11, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH AN ALARM AS A RESULT OF A LOOSE DRIVE SUPPORT DISK. THE DEVICE WAS RETURNED WITH MISSING END CAP STICKER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED REGARDING ISSUES DURING PRIME/REWIND. THE BLOOD GLUCOSE READING WAS 389MG/DL. THE CALLER STATED THAT INSULIN SQUIRTED OUT DURING THE MANUAL PRIME PROCESS, AND THE INSULIN PUMP ALARMED. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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 43 YR