BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3972245 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-88640
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 1, 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

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP PASSED THE REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, EXCESSIVE NO DELIVERY ALARM AND DISPLACEMENT TEST. NO MOTOR ERROR ALARM NOTED. THE MOTOR PASSED THE MOTOR TEST. MINOR SCRATCHED LCD WINDOW, CRACKED DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE AND LIP. NO EXCESSIVE NO DELIVERY ALARM WAS OBSERVED.

    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 AND NO DELIVERY DURING THE RESERVOIR CHANGING AND PRIMING PROCESS. THE BLOOD GLUCOSE READING WAS 230 MG/DL. THE CUSTOMER STATED THAT THERE HAD BEEN NO PHYSICAL DAMAGE TO THE DEVICE OTHER THAN A SCRATCH OR TWO ON THE WINDOW BUT THE DISPLAY IS LEGIBLE. NO SIGNIFICANT EVENTS LEADING TO THE ALARM WERE OBSERVED. THE CUSTOMER STATED THAT HE WAS ABLE TO REWIND THE INSULIN PUMP BUT WAS UNABLE TO TROUBLESHOOT DUE TO THE MOTOR ERROR. HE DECLINED RETURN OF THE INFUSION SET AND RESERVOIR FOR ANALYSIS. IT WAS ALSO OBSERVED THAT THE UNITS LEFT IN THE RESERVOIR IN THE STATUS MENU READ 100.0 UNITS BUT CHANGED TO 0.0 UNITS WHEN THE MOTOR ERROR ALARMED. ADVISED DISCONTINUATION OF THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447718 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR