BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3942395 · Received July 17, 2014

    Report

    Report Number
    3004209178-2014-87551
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 14, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP PASSED DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, AND EXCESSIVE NO DELIVERY ALARM TEST. NO MOTOR ERROR ALARM OR EXCESSIVE NO DELIVERY ALARMS NOTED. INSULIN PUMP UNABLE TO PRIME DURING PRIME TEST DUE TO UNIT RECEIVED WITH A MINOR SCRATCH ON LCD WINDOW, CRACKED RESERVOIR TUBE LIP, AND CRACKED BATTERY TUBE THREADS. INSULIN PUMP PENDING MOTOR TEST.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED UNABLE TO PRIME DURING PRIME/A33 TEST DUE TO FAULTY FORCE SENSOR RESISTOR. THE INSULIN PUMP PASSED DISPLACEMENT, REWIND, BASIC OCCLUSION, AND EXCESSIVE NO DELIVERY ALARM TESTS. NO MOTOR ERROR ALARM OR EXCESSIVE NO DELIVERY ALARMS NOTED AND THE MOTOR PASSED MOTOR TEST. THE INSULIN PUMP HAD MINOR SCRATCHED LCD WINDOW, CRACKED RESERVOIR TUBE LIP AND CRACKED BATTERY TUBE THREADS.

    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. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR DURING PRIMING PROCESS. THE BLOOD GLUCOSE READING WAS 392 MG/DL. NO SIGNIFICANT EVENTS LEADING TO THE ALARM WERE OBSERVED. THE CUSTOMER STATED THAT HE WAS ABLE TO REWIND THE INSULIN PUMP. IT WAS ALSO REPORTED THAT THE DEVICE ALARMED NO DELIVERY BUT THE CUSTOMER DECLINED TROUBLESHOOTING FOR THIS ISSUE. ADVISED DISCONTINUATION OF THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419567 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR