BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4201274 · Received October 27, 2014

    Report

    Report Number
    2032227-2014-42843
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 21, 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
    TN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED DURING THE DISPLACEMENT TEST DUE TO A MOTOR WITH A HIGH IDLE CURRENT DRAW. THE DISPLACEMENT TEST AND PRIME TESTS COULD NOT BE COMPLETED DUE TO THE ALARMS DURING THE DISPLACEMENT TEST. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED CASE AT THE DISPLAY WINDOW CORNERS, CRACKED BELT CLIP SLOT AND MINOR SCRATCHES ON THE 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

    THE CUSTOMER REPORTED THAT THE INSULIN ALARMED COMPROMISED FORCE SENSOR SYSTEM. CUSTOMER STATED THAT HE GOT THE ALARM AND THE INSULIN PUMP RESET ITSELF SO HE REWIND IT AND WENT THROUGH THE SAME PROCESS AND GOT COMPROMISED FORCE SENSOR SYSTEM ALARM. TROUBLESHOOTING WAS DONE. CUSTOMER'S BLOOD GLUCOSE WAS 200 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
    682835 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR