BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4243897 · Received November 11, 2014

    Report

    Report Number
    2032227-2014-50719
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE FUNCTIONAL TESTS. HOWEVER, THE DEVICE HAD INTERMITTENT BUTTON RESPONSE DUE TO MOISTURE DAMAGE TO THE KEYPAD TRACES. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED CASE NEAR THE DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS, AND A 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

    THE CUSTOMER'S FATHER REPORTED THAT THE INSULIN PUMP ALARMED BUTTON ERROR, NO DELIVERY AND CUSTOMER HAD HIGH BLOOD GLUCOSE. CUSTOMER STATED SHE GOT THE BUTTON ERROR WHEN SHE WAS GIVING BOLUS TO HERSELF. CUSTOMER STATED HAD HIGH BLOOD GLUCOSE AT THAT TIME BUT CANNOT RECALL THE BLOOD GLUCOSE READING. CUSTOMER TREATED WITH MANUAL INJECTION. CUSTOMER STATED THAT IN THE PAST HE WENT TO PRIME THE INSULIN PUMP AND GOT NO DELIVERY ALARM. CUSTOMER'S BLOOD GLUCOSE AT THAT TIME WAS AROUND 130 MG/DL. FATHER TOO THE SET OUT AND DID A REWIND AND WAS ABLE TO GET IT TO WORK. UNABLE TO TROUBLESHOOT DUE TO BUTTON ERROR. 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
    725483 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR