BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 4862610 · Received June 23, 2015

    Report

    Report Number
    2032227-2015-19279
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    May 21, 2013
    Report Date
    June 5, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED ALARMING A SOFTWARE ERROR. THE COMPROMISED FORCE SENSOR SYSTEM ALARM COULD NOT BE VERIFIED DUE TO THE SOFTWARE ALARM. THE UNIT WAS RECEIVED WITH MINOR SCRATCHES ON THE LIQUID CRYSTAL DISPLAY WINDOW. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED CASE AT THE DISPLAY WINDOW CORNERS, CRACKED CASE AT THE RESERVOIR TUBE WINDOW CORNERS AND CRACKED RESERVOIR TUBE WINDOW. THE DEVICE WAS RECEIVED WITH A BROKEN RESERVOIR TUBE LIP AND BROKEN BATTERY TUBE THREADS. THE UNIT WAS ALSO RECEIVED WITH A CORRODED BATTERY TUBE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM AND THAT INSULIN SQUIRTED OUT DURING THE MANUAL PRIME PROCESS. THE CALLER DID NOT KNOW THE BLOOD GLUCOSE READING. THE CALLER STATED THAT THE PISTON CONTINUED TO MOVE FORWARD AFTER CONTACTING THE RESERVOIR, CAUSING INSULIN TO SQUIRT OUT, FOLLOWED BY THE INSULIN PUMP ALARMING. THE CUSTOMER WAS UNABLE TO EXIT THE PRIME PROCESS AND ATTEMPTED TO RETRY THE PROCEDURE WITH A DIFFERENT SET. THE CALLER NOTED THAT THE INSULIN PUMP HAD NOT BEEN BUMPED, DROPPED OR EXPOSED TO WATER. THE DRIVE SUPPORT CAP DID NOT APPEAR TO HAVE BEEN DAMAGED. THE CALLER WAS ADVISED TO REPLACE THE INSULIN PUMP AND A REQUEST WAS MADE TO HAVE THE DEVICE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406065 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-712WWL

    Patients

    Seq Age Sex Outcome Treatment
    1