BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2905643 · Received January 9, 2013

    Report

    Report Number
    3004209178-2013-90164
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    December 21, 2012
    Report Date
    December 22, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH OPERATING CURRENTS WITHIN SPECIFICATION. THE INSULIN PUMP PASSED THE REWIND, BASIC OCCLUSION TEST, PRIME AND DISPLACEMENT. HOWEVER, THE INSULIN PUMP WAS RECEIVED STUCK IN THE MOTOR ERROR LOOP DURING BOLUS AND BASAL DELIVERY. ERROR ALARM CONFIRMED IN THE HISTORY FILE. THE MOTOR WAS TESTED OUTSIDE THE DEVICE AND PASSED. THE MOTOR MAY HAVE HAD AN INTERMITTENT FAILURE THAT WAS NOT DETECTED DURING OUR TESTING. UNABLE TO PERFORM ERROR TEST, OCCLUSION TEST, EXCESSIVE NO DELIVERY TEST DUE TO MOTOR ERROR ALARMS.

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH OPERATING CURRENTS WITHIN SPECIFICATIONS. THE DEVICE PASSED THE REWIND, BASIC OCCLUSION, PRIME, AND DISPLACEMENT TEST. HOWEVER, THE INSULIN PUMP WAS RECEIVED STUCK IN THE MOTOR LOOP DURING BOLUS AND BASAL DELIVERY. THE ERROR ALARMS WERE CONFIRMED IN THE ALARM HISTORY. THE MOTOR WAS TESTED OUTSIDE THE UNIT AND PASSED. THE MOTOR MAY HAVE AN INTERMITTENT FAILURE THAT WAS NOT DETECTED DURING OUR TESTING. FURTHER TESTING COULD NOT BE PERFORMED DUE TO THE MOTOR ERROR ALARMS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING IN THE EMERGENCY ROOM DUE TO DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE OF 506MG/DL. THE CALLER STATED THAT HE RECEIVED MOTOR ERROR ALARMS AND OTHER ERROR ALARMS. ADVISED THE CUSTOMER THAT THE INSULIN PUMP 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
    12528 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization