BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4181499 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39588
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 18, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD A BROKEN RESERVOIR TUBE LIP, BROKEN BATTERY TUBE THREADS, A CRACKED BELT CLIP SLOT, MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED CASE AT A DISPLAY WINDOW CORNER, SCRATCHED RESERVOIR TUBE WINDOW, CRACKED RESERVOIR TUBE AND CRACKED BATTERY TUBE THREADS. THE INSULIN PUMP PASSED THE DISPLACEMENT TEST, BASIC OCCLUSION TEST, PRIME TEST, OCCLUSION TEST AND EXCESSIVE NO DELIVERY ALARM TEST.

    Additional Manufacturer Narrative · 1

    (B)(4).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 CUSTOMER HAD PHYSICAL DAMAGE ON THE INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS OVER 600 MG/DL. CUSTOMER'S BLOOD GLUCOSE LEVEL HAS STAYED THE SAME FOR SEVERAL HOURS AT LEAST. CUSTOMER STATED THAT THE DAMAGE TO THE RESERVOIR COMPARTMENT KEEPS THE RESERVOIR FROM STAYING IN THE PUMP PROPERLY AND IT IS BEING PUSHED OUT BY THE PISTON. CUSTOMER'S RESERVOIR WILL NO LONGER LOCK INTO PLACE. CUSTOMER STATED THERE CRACKS AND MISSING CASE MATERIAL ON THE PUMP. THERE IS DAMAGE AROUND THE BATTERY CAP AND BATTERY BAY AND LIP. CUSTOMER STATED THE PUMP WAS DROPPED PREVIOUSLY. INSULIN PUMP WILL NEED TO BE REPLACED DUE TO PHYSICAL DAMAGE. CUSTOMER STATED THAT THEY ARE HIGH BECAUSE THE RESERVOIR WILL NOT LOCK INTO THE PUMP. CUSTOMER DECLINED TROUBLESHOOTING HIGH BLOOD GLUCOSE LEVELS. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660932 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAL A8523NALJ

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR