BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4201269 · Received October 27, 2014

    Report

    Report Number
    2032227-2014-42838
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 25, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED MOTOR ERROR DURING OCCLUSION TEST DUE TO FAULTY FORCE SENSOR RESISTOR. UNABLE TO VERIFY A33 ALARM DUE TO MOTOR ERROR. THE INSULIN PUMP PASSED DISPLACEMENT, REWIND, BASIC OCCLUSION, PRIME/A33, EXCESSIVE NO DELIVERY TESTS AND PASSED THE MOTOR TEST. THE INSULIN PUMP HAS CRACKED RESERVOIR TUBE LIP, BROKEN BATTERY TUBE THREADS, CASE CRACKED AT THE DISPLAY WINDOW CORNER, MINOR SCRATCHED LCD WINDOW, SCRATCHED RESERVOIR TUBE WINDOW, RESERVOIR TUBE CRACKED, RESERVOIR TUBE WINDOW CRACKED AND BROKEN BELT CLIP SLOT.

    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

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR, COMPROMISED FORCE SENSOR SYSTEM AND HAD LOW BLOOD GLUCOSE. CUSTOMER STATED THE ALARM OCCURRED DURING PRIME PROCESS. CUSTOMER STATED THE INSULIN SQUIRTED OUT DURING MANUAL PRIME. TROUBLESHOOTING WAS DONE FOR MOTOR ERROR, COMPROMISED FORCE SENSOR SYSTEM AND LOW BLOOD GLUCOSE. CUSTOMER'S BLOOD GLUCOSE WAS 54 MG/DL. CUSTOMER TREATED WITH GLUCOSE TABLETS. CUSTOMER'S BLOOD GLUCOSE AT THE TIME OF LOW BLOOD GLUCOSE WAS 56 MG/DL. ADVISED CUSTOMER THE INSULIN PUMP WOULD BE REPLACED. ADVISED TO DISCONTINUE USING THE PUMP AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROVIDER. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681292 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR