BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2912253 · Received January 11, 2013

    Report

    Report Number
    3004209178-2013-90232
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 27, 2012
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE REWIND AND DISPLACEMENT TEST. HOWEVER, UNABLE TO PRIME THE INSULIN PUMP DURING PRIME TEST DUE TO FAULTY FORCE SENSOR. UNABLE TO PERFORM BASIC OCCLUSION TEST, OCCLUSION, EXCESSIVE NO DELIVERY TEST OR VERIFY MOTOR ERROR ALARMS DUE TO PRIME ANOMALY. THE MOTOR WAS TESTED OUTSIDE THE DEVICE AND PASSED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR. THE BLOOD GLUCOSE READING WAS UNKNOWN. TROUBLESHOOTING WAS PERFORMED. THE CALLER STATED THAT THE DEVICE WAS NOT EXPOSED TO A HIGH MAGNETIC FIELD. ASSISTED THE CUSTOMER TO RUN THE DISPLACEMENT TEST AND THE TEST FAILED. ADVISED THE CALLER THAT THE INSULIN PUMP WOULD BE REPLACED AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16569 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MMT-522NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR