BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3980960 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-89934
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS UNABLE TO PRIME DURING PRIME TEST DUE TO A FAULTY FORCE SENSOR. THE DEVICE PASSED THE DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, AND EXCESSIVE NO DELIVERY TEST. NO MOTOR ERROR ALARM NOTED. THE MOTOR PASSED THE MOTOR TEST. THE UNIT WAS RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS, CRACKED BELT CLIP SLOT, AND BROKEN RESERVOIR TUBE LIP.

    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 ON THE INSULIN PUMP. THE BLOOD GLUCOSE READING WAS 343 MG/DL. SHE STATED THE BLOOD GLUCOSE WAS HIGH BECAUSE SHE DRANK A SODA AND THAT SHE TREATED WITH MANUAL INJECTION. SHE COULD NOT RECALL ANY SIGNIFICANT EVENT LEADING TO THIS ALARM AND STATED THAT THE INSULIN PUMP HAD NOT BEEN EXPOSED TO A STRONG MAGNETIC FIELD OR MRI. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457254 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR