BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3971922 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-88590
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO A17 ALARM OR A21 ALARM NOTED. UNIT PASSED THE SELF TEST AND A21 ERROR TEST. PUMP RECEIVED WITH A47 ALARM IN THE HISTORY FILE. A47 ALARM DUE TO CORRUPTED HISTORY FILE. PUMP PASSED THE REWIND, BASIC OCCLUSION, PRIME/A33 AND DISPLACEMENT TESTS. PUMP RECEIVED WITH STUCK MOTOR ERROR ALARM LOOP DURING BOLUS DELIVERY. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED. THE MOTOR MAY HAVE HAD AN INTERMITTENT FAILURE THAT WAS NOT DETECTED DURING OUR TESTING. UNABLE TO CONFIRM E70 ALARM DUE TO ERASED HISTORY FILE. UNIT HAD SCRATCHED DISPLAY WINDOW AND CRACKED DISPLAY WINDOW CORNER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ISSUES WITH THE INSULIN PUMP. CUSTOMER STATED THAT THERE IS A MOTOR ERROR ALARM. ASSISTED CUSTOMER IN CLEARING THE ALARM BY DISCONNECTING FROM THE INSULIN PUMP. FURTHERMORE, CUSTOMER RECEIVED VARIOUS OTHER ALARMS. CUSTOMER'S BLOOD GLUCOSE IS NOT PROVIDED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446429 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR