BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4242843 · Received November 11, 2014

    Report

    Report Number
    2032227-2014-49937
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 12, 2014
    Report Date
    October 12, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    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).

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH PROTRUDED AND LOOSE DRIVE SUPPORT DISK. INSULIN PUMP HAD MINOR SCRATCHES ON DISPLAY WINDOW AND CRACKED RESERVOIR TUBE LIP. INSULIN PUMP WAS UNABLE TO PRIME DURING THE PRIME TEST, DUE TO PROTRUDED AND LOOSE DRIVE SUPPORT DISK. NO PRIME ALARM NOTED. NO MOTOR SOUNDS ANOMALY DURING TESTING NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER'S MOTHER THAT THE CUSTOMER HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM ON THE INSULIN PUMP. CUSTOMER WAS IN THE REWIND PROCESS WHEN THE PUMP SOUNDED OFF. CUSTOMER'S MOTHER CLAIMED TO HEAR A WEIRD SOUND FROM THE MOTOR. CUSTOMER'S MOTHER STATED THAT THE DRIVE SUPPORT CAP WAS PROTRUDING AND LOOSE. SHE CONFIRMED THAT IT IS NO LONGER CONNECTED TO THE CUSTOMER. CUSTOMER'S MOTHER PRESSED THE CAP AND SHE GOT IT BACK IN. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 270 MG/DL. CUSTOMER TREATED WITH MANUAL INJECTIONS. IT WAS EXPLAINED THAT THE ALARM WAS RECEIVED WHEN THE PUMP WAS BEING REWOUND AND WHEN THE ACT BUTTON WAS PRESSED. INSULIN PUMP WILL NEED TO BE REPLACED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725746 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 15 YR