BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3090730 · Received May 2, 2013

    Report

    Report Number
    3004209178-2013-93078
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 3, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS UNABLE TO PRIME DURING PRIME TEST DUE TO PROTRUDED/LOOSE DRIVE SUPPORT DISK. UNABLE TO PERFORM THE BASIC OCCLUSION TEST, OCCLUSION AND EXCESSIVE NO DELIVERY TESTS DUE TO PRIME/FILL ANOMALY. THE INSULIN PUMP HAD A SEVERELY SCRATCHED DISPLAY WINDOW, SCRATCHED CASE, CRACKED CASE AT DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS AND A BROKEN BELT CLIP SLOT.

    Description of Event or Problem · 1

    CUSTOMER CALLED AND REPORTED DAMAGE TO THE INSULIN PUMP, IT HAS A CRACK. CUSTOMER ALSO STATED THAT THE DRIVE SUPPORT CAP IS PROTRUDED. ADVISED CUSTOMER TO DISCONTINUE USE OF THE INSULIN PUMP. ADVISED CUSTOMER THAT INSULIN PUMP WILL NEED TO BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191324 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR