BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3945664 · Received July 21, 2014

    Report

    Report Number
    3004209178-2014-87916
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    May 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP HAD MOISTURE DAMAGE ON KEYPAD TRACES. NO UNEXPECTED LOW RESERVOIR ALARM NOTED. INSULIN PUMP HAD A CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHES ON DISPLAY WINDOW AND CRACKED CASE NEAR DISPLAY WINDOW CORNERS. INSULIN PUMP PASSED PRIME, DISPLACEMENT, BASIC OCCLUSION, OCCLUSION AND EXCESSIVE NO DELIVERY ALARM TESTS. NO PRIME ANOMALY NOTED. FIXED PRIME FUNCTIONED PROPERLY DURING TESTING, 5 UNITS WERE PROGRAMMED. ALL BUTTONS FUNCTIONED PROPERLY.

    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

    IT WAS REPORTED THAT THE CUSTOMER WAS TRYING TO FILL THE CANNULA WITH 5 UNITS OF INSULIN, BUT THE INSULIN PUMP KEPT RESETTING TO 10 UNITS ON ITS OWN. THE CUSTOMER STATED THAT THEY DID NOT CHANGE THE AMOUNT MANUALLY TO 10 UNITS. THEY ADJUSTED THE UNIT TO 5 UNITS AND WHEN THEY WENT BACK TO FILL THE CANNULA THE DEVICE REVERTED BACK TO 10 UNITS AGAIN. THE CUSTOMER ALSO STATED THAT THE INSULIN PUMP ALARMED LOW RESERVOIR THE MORNING OF THE PHONE CALL. THE CUSTOMER'S BLOOD GLUCOSE WAS 266 MG/DL. THEY STATED THAT THE REASON FOR THE HIGH BLOOD GLUCOSE WAS THAT SHE HAD A LOW BLOOD GLUCOSE OF 36 MG/DL THE NIGHT PRIOR TO THE PHONE CALL AND HAD A COUPLE OF GLASSES OF ORANGE JUICE. THE HIGH BLOOD GLUCOSE WAS TREATED WITH THE INSULIN PUMP. THE CUSTOMER DECLINED TROUBLESHOOTING FOR THE HIGH BLOOD GLUCOSE. SHE STATED THAT THE LOW BLOOD GLUCOSE WAS DUE TO OVERCORRECTING FOR THE AMOUNT OF THE CARBOHYDRATES EATEN LAST NIGHT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424531 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR