BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3092951 · Received May 3, 2013

    Report

    Report Number
    2032227-2013-01647
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 7, 2013
    Report Date
    April 8, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH MOTOR ERROR ALARM DURING REWIND DUE TO ENCODER OUT OF PHASE. UNABLE TO PERFORM DISPLACEMENT TEST DUE TO CONSTANT MOTOR ERROR ALARM. UNABLE TO PERFORM BASIC OCCLUSION TEST, OCCLUSION TEST AND EXCESSIVE NO DELIVERY TEST DUE TO CONSTANT MOTOR ERROR ALARM. DRIVE SUPPORT DISK WAS INSPECTED AND NO ANOMALY WAS 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

    THE CUSTOMER CALLED TO REPORT THAT THE DRIVE SUPPORT CAP WAS PROTRUDING. THE CUSTOMER ALSO REPORTED A MOTOR ERROR ALARM. THE REPORTED BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 299 MG/DL. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195210 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR