BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3202097 · Received July 2, 2013

    Report

    Report Number
    2531779-2013-09543
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 27, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 10/17/2013. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/04/2013 WITH THE FOLLOWING FINDINGS: THE BLACK BOX REVIEW SHOWS SEVERAL ¿NO CARTRIDGE DETECTED¿ WARNING ON THE REPORTED EVENT DATE. THE PUMP POWERS ¿ON¿ AND DISPLAYS ¿VERIFY¿ SCREEN. THE DISPLAY IS FADED AND DISCOLORED. THE PUMP¿S COVER WAS REMOVED AND A TEST DISPLAY SCREEN WAS MOUNTED, THE PUMP WAS ABLE TO POWER UP WITH A FULLY ILLUMINATED AND COLORED DISPLAY. THE PUMP PERFORMED ¿REWIND¿ STEP CORRECTLY BUT THE PISTON WAS UNABLE TO DETECT THE CARTRIDGE UPON THE FIRST ¿LOAD¿ ATTEMPT. ¿LOAD STEP MALFUNCTION¿ WAS DUPLICATED. THE PUMP WAS DISASSEMBLED. MOISTURE CORROSION WAS FOUND TO THE FORCE SENSOR PLATE. THE FORCE SENSOR RESISTANCE MEASUREMENT IS ABOVE SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOAD STEP MALFUNCTION) ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301827 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR