BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 4761334 · Received May 9, 2015

    Report

    Report Number
    3004209178-2015-54727
    Event Type
    Malfunction
    Date Received
    May 9, 2015
    Date of Event
    April 17, 2015
    Report Date
    April 17, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LZG
    PMA / PMN Number
    K053177
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RECEIVED WITH A MOTOR ERROR ALARM DURING THE REWIND DUE TO AN OUT OF PHASE MOTOR ENCODER. THE PUMP ALSO HAD A CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR DURING THE REWIND PROCESS AND HAD SEVERAL MOTOR ERROR ALARMS FOUND IN THE DEVICE'S ALARM HISTORY. THE CALLER DID NOT PROVIDE THE BLOOD GLUCOSE READING BUT STATED THAT THE BLOOD GLUCOSE LEVELS WERE NORMAL AND DID NOT REQUIRE MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305766 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-712EWS

    Patients

    Seq Age Sex Outcome Treatment
    1