BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4230945 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48325
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 7, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH CURRENTS IN SPECIFICATION. NO UNEXPECTED WEAK BATTERY. THE INSULIN PUMP PASSED REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, EXCESSIVE NO DELIVERY ALARM AND DISPLACEMENT TEST. NO MOTOR ERROR ALARM. MOTOR PASSED MOTOR TEST. NO BUTTON ERROR ALARM. THE INSULIN PUMP HAD AN INTERMITTENT BUTTON RESPONSE DUE TO MOISTURE DAMAGE KEYPAD TRACE. THE INSULIN PUMP HAD MINOR SCRATCHES ON LCD WINDOW, CRACKED CASE NEAR DISPLAY WINDOW CORNERS AND CRACKED 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. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A WEAK BATTERY ALARM ON THE INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 168 MG/DL. IT WAS EXPLAINED THAT THE PUMP WILL FUNCTION BUT THE BATTERY LIFE WILL BE SHORTER THAN EXPECTED. CUSTOMER HAS BEEN GETTING WEAK BATTERY ALARMS WITH A DIFFERENT BATTERY. CUSTOMER STATED THAT THIS HAPPENED NUMEROUS TIMES. CUSTOMER WAS USING AN ENERGIZER BATTERY. IT WAS EXPLAINED THAT A WEAK BATTERY ALERT WILL OCCUR PRIOR TO A FAILED BATTERY TEST OR LOW BATTERY ALERT. CUSTOMER ALSO HAD A MOTOR ERROR ALARM. CUSTOMER DOES NOT USE SENSOR FEATURE ON THE PUMP. CUSTOMER WAS ABLE TO COMPLETE THE REWIND SEQUENCE. CUSTOMER WAS ADVISED TO RETURN THE PUMP WITH THE BATTERY AND ZERO OUT THE BASAL RATES. INSULIN PUMP WILL NEED TO BE REPLACED. CUSTOMER WAS ADVISED TO REVERT TO A BACK-UP PLAN PER HEALTH CARE PROFESSIONAL'S INSTRUCTIONS. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713282 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR