BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4233744 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-49167
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO UNEXPECTED MOTOR ERROR ALARMS OR NO UNEXPECTED ALARMS DURING BATTERY CHANGES NOTED. INSULIN PUMP PASSED DISPLACEMENT TEST, REWIND TEST, BASIC OCCLUSION TEST, PRIME TEST, OCCLUSION TEST AND EXCESSIVE NO DELIVERY TEST. INSULIN PUMP HAD MINOR SCRATCHES ON LCD WINDOW, CRACKED RESERVOIR TUBE LIP, SCRATCHES ON RESERVOIR TUBE WINDOW AND CRACKED BATTERY TUBE THREADS. LEAKING MOTOR OIL NOTED.

    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

    CUSTOMER REPORTED THAT THE INSULIN PUMP RETURNED A MOTOR ERROR ALARM DURING BOLUS. CUSTOMER DID NOT REPORT ANY SIGNIFICANT EVENTS LEADING UP TO THE ERROR ALARMS. CUSTOMER ALSO REPORTED HAVING AN ISSUE WHERE MULTIPLE BATTERY CHANGES WERE REQUIRED. BLOOD GLUCOSE LEVEL WAS 120 MG/DL AT THE TIME OF THE CALL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714601 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR