BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP S

    MDR report key: 3133565 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-94154
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 13, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PATIENT

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED STUCK IN MOTOR ERROR ALARM LOOP DURING BOLUS DELIVERY. ERROR ALARM CONFIRMED IN THE HISTORY FILE. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED. THE MOTOR MAY HAVE HAD AN INTERMITTENT FAILURE THAT WAS NOT DETECTED DURING OUT TESTING. UNABLE TO PERFORM OCCLUSION, THE EXCESSIVE NO DELIVERY AND ALARM TEST DUE TO CONSTANT MOTOR ERROR ALARM DURING BOLUS DELIVERY. ALL OPERATING CURRENTS ARE WITHIN SPECIFICATIONS, NO UNEXPECTED LOW BATTERY OR OFF NO POWER ALARM NOTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR. THE BLOOD GLUCOSE READING WAS 145MG/DL. THE DEVICE WAS TESTED OK. A DAY LATER THE CUSTOMER CALLED BACK TO REPORT RECURRING MOTOR ERROR ALARMS. THE DISPLACEMENT TEST WAS PERFORMED AND THE TEST FAILED. THE SELF TEST WAS COMPLETED AND PASSED. ADVISED THE CUSTOMER THAT THE DEVICE WOULD BE REPLACED AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236923 PARADIGM REAL-TIME INSULIN INFUSION PUMP S INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR