BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2272305 · Received August 26, 2011

    Report

    Report Number
    3004209178-2011-82706
    Event Type
    Malfunction
    Date Received
    August 26, 2011
    Date of Event
    June 28, 2011
    Report Date
    August 11, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH AN ERROR ALARM AND THE SCREEN WAS STUCK ON THE PRIME MENU AS A RESULT OF A FAULTY MOTHERBOARD.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP HAD AN ERROR ALARM AFTER CHANGING THE BATTERY. THE CUSTOMER STATED THAT THE INSULIN PUMP KEPT RESETTING ITSELF AND DID NOT ALLOW SELECTING THE PRIME MENU ONCE IT IS DONE REWINDING. ADVISED THE CUSTOMER TO REVERT TO BACK UP PLAN. THE CUSTOMER STATED THAT SHE WILL TREAT HER HIGH BLOOD GLUCOSE WITH A MANUAL INJECTION. 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 MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR