BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4123460 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29718
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP PASSED THE DISPLACEMENT, PRIME/A33 AND EXCESSIVE NO DELIVERY TEST. NO EXCESSIVE NO DELIVERY ALARM NOTED. PUMP RECEIVED WITH CRACKED RESERVOIR TUBE LIP AND SCRATCHED LCD WINDOW. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP FREQUENTLY ALARMS NO DELIVERY AND AIR BUBBLES WERE NOTICEABLE IN THE TUBING. HIGH PRESSURE TEST WAS PERFORMED AND DID NOT PASS. CUSTOMER STATED THAT THE ALARM WAS PERSISTENT. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 142 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600093 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-554LWWP

    Patients

    Seq Age Sex Outcome Treatment
    1