BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3972060 · Received July 31, 2014

    Report

    Report Number
    2032227-2014-05074
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    May 18, 2014
    Report Date
    July 3, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE REWIND, BASIC OCCLUSION TEST, PRIME/A33 TEST AND DISPLACEMENT TEST. HOWEVER, THE DEVICE WAS RECEIVED STUCK IN THE MOTOR ERROR LOOP DURING BOLUS/BASAL DELIVERY. UNABLE TO CONFIRMED E70 ERROR ALARM DUE TO ERASED HISTORY FILE. THE MOTOR WAS TESTED OUTSIDE THE DEVICE AND PASSED. THE MOTOR MAY HAVE HAD AN INTERMITTENT FAILURE THAT WAS NOT DETECTED DURING TESTING. THE DRIVE SUPPORT DISK WAS INSPECTED AND NO ANOMALY WAS NOTED. UNIT RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS. THE DEVICE WAS RECEIVED WITH SCRATCHED LCD WINDOW.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE INSULIN PUMP ALARMED MOTOR ERROR DURING PRIMING. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 188 MG/DL. CUSTOMER DOES NOT RECALL ANY PREVIOUS SIGNIFICANT EVENT THAT MAY HAVE CAUSED THE DEVICE TO ALARM. THE DEVICE WAS NOT EXPOSED TO AN MRI BUT WAS WEARING THE DEVICE DURING A COLONOSCOPY ABOUT FOUR WEEKS PRIOR TO ALARM. CUSTOMER WAS ADVISED TO DISCONNECT FROM THE DEVICE. CUSTOMER DOES NOT USE THE SENSOR FEATURE. CUSTOMER STATED HE COULD REWIND THE DEVICE. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447304 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR