BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3081768 · Received April 29, 2013

    Report

    Report Number
    3004209178-2013-92858
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 5, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP RECEIVED WITH PRIME ALARM DURING PRIME TEST AND ALARMED MOTOR ERROR DURING BASIC OCCLUSION TEST DUE TO PROTRUDED/LOOSE DRIVE SUPPORT DISK. NO PRIME ALARM NOTED. MOTOR PASSED MOTOR TEST. THE INSULIN PUMP HAD A SCRATCHED DISPLAY WINDOW AND A BROKEN BELT CLIP SLOT. UNABLE TO PERFORM OCCLUSION TEST AND EXCESSIVE NO DELIVERY TEST DUE TO PRIME/FILL ANOMALY. THE INSULIN PUMP PASSED THE DISPLACEMENT AND REWIND TESTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED PRIME ERROR ALARM AFTER REWINDING THE INSULIN PUMP. THE INSULIN PUMP KEPT PROMPTING FOR A REWIND. BLOOD GLUCOSE HAS NOT BEEN CHECKED FOR TWO WEEKS. DRIVE SUPPORT CAP IS NORMAL. DURING TROUBLESHOOTING, CUSTOMER IS RECEIVING PRIME ALARM. ADVISED CUSTOMER TO DISCONTINUE USE OF THE INSULIN PUMP, THE DEVICE WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183932 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR