BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4223359 · Received November 4, 2014

    Report

    Report Number
    2032227-2014-46831
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINDINGS: PUMP WAS RECEIVED WITH MOTOR ERROR ALARM DURING OCCLUSION TEST AND UNABLE TO PRIME AT 2.5 LBS DURING PRIME/A33 TEST DUE TO FAULTY FSR (GOLD). MOTOR PASSED MOTOR TEST. UNIT HAD MINOR SCRATCHED LCD WINDOW, CRACKED DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS AND CRACKED RESERVOIR TUBE LIP.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP FAILED THE SELF TEST. CUSTOMER'S CURRENT BLOOD GLUCOSE READING WAS 241 MG/DL. ADVISED DISCONTINUATION OF THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707446 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR