BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3942387 · Received July 17, 2014

    Report

    Report Number
    3004209178-2014-87620
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 17, 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
    IN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP HAD CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHES ON THE DISPLAY WINDOW AND CRACKED CASE NEAR DISPLAY WINDOW CORNERS. THE DEVICE PASSED THE PRIME, DISPLACEMENT, BASIC OCCLUSION AND EXCESSIVE NO DELIVERY ALARM TESTS. NO EXCESSIVE NO DELIVERY ALARMS NOTED.

    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 NO DELIVERY DURING A BOLUS ATTEMPT. THE BLOOD GLUCOSE READING WAS 127 MG/DL. THE CUSTOMER STATED THAT HE HAS GONE THROUGH 6 INSERTION SETS AND HAS TRIED VARIOUS SITE LOCATIONS ON THE BODY ALSO. HE REPORTED THAT HE HAS TRIED ALL REMEDIES AND DOES NOT WANT TO TROUBLESHOOT. ADVISED DISCONTINUATION AND REPLACEMENT OF THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419046 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR UNOMEDICAL PRODUCT