BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3945120 · Received July 18, 2014

    Report

    Report Number
    2032227-2014-04562
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    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 PASSED THE DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND NO DELIVERY TEST. NO MOTOR ERROR ALARM NOTED. THE MOTOR PASSED THE MOTOR TEST. THE DEVICE WAS RECEIVED WITH CRACKED BATTERY TUBE THREADS, RESERVOIR TUBE AND LIP, AND MINOR SCRATCHED DISPLAY WINDOW.

    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

    CUSTOMER REPORTED RECEIVING A MOTOR ERROR ALARM AND A NO DELIVERY ALARM ON THE INSULIN PUMP. THE BLOOD GLUCOSE READING WAS 600 MG/DL. CUSTOMER TREATED WITH MANUAL INJECTION. CUSTOMER REPORTED THAT THE MOTOR ERROR OCCURRED DURING THE BOLUS DELIVERY. SHE STATED THAT THERE HAD BEEN POSSIBLY MOISTURE DAMAGE AND THAT CONDENSATION COULD BE SEEN INSIDE THE SCREEN. SHE STATED THAT SHE HAD WORN THE INSULIN PUMP ON A WAISTBAND AGAINST THE BODY. SHE STATED THAT THE INSULIN PUMP HAD NOT BEEN EXPOSED TO A STRONG MAGNETIC FIELD OR MRI. CUSTOMER WAS ABLE TO REWIND THE INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421901 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR