BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3120571 · Received May 20, 2013

    Report

    Report Number
    2531779-2013-06731
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Report Date
    April 21, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS ORIGINALLY RETURNED ON (B)(4) 2012 AND INVESTIGATED ON (B)(4) 2012 FOR A REPORTED KEYPAD/BUTTON ISSUE. THIS COMPLAINT WAS PREVIOUSLY REPORTED. THE PUMP WAS RETRIEVED FROM ARCHIVE AND AN INVESTIGATION FOR THIS NEW ISSUE WAS COMPLETED ON (B)(4) 2013 WITH THE FOLLOWING RESULTS. THE ALERT DATE OF THIS COMPLAINT WAS (B)(6) 2013. THE KEYPAD ISSUES WILL NOT BE DISCUSSED HERE. THE DISPLAY SCREEN LENS WAS SCRATCHED. INVESTIGATION COULD NOT BE COMPLETED DUE TO THE KEYPAD FAILURE. THE KEYPAD BUTTONS WERE REPAIRED IN ORDER TO EVALUATE THE CURRENT COMPLAINT. THE BLACK BOX CONTAINED DATA BETWEEN 08/09/2012 AND 08/17/2013. REVIEW OF THE BLACK BOX SHOWED THAT PRIMING EVENTS OCCURRED FOLLOWING BASAL AND BOLUS DELIVERIES UNRELATED TO CARTRIDGE FILL, REWIND, AND LOAD STEPS. IT IS UNKNOWN WHY THE USER COMPLETED THESE PRIME OPERATIONS. TWO LOSS OF PRIME EVENTS WERE OBSERVED IN THE BLACK BOX DUE TO LOW NON-ZERO FORCE. THE LOSS OF PRIME WARNINGS WERE CONFIRMED WITHIN 33 MINUTES. OCCLUSION ALARMS WERE RECORDED IN THE PUMP ALARM HISTORY. NO ALARMS OR DELIVERY INTERRUPTIONS WERE DUPLICATED DURING DURATION TEST. THE PUMP PASSED THE 29-HOUR FLOW ACCURACY TESTING. THE FORCE SENSOR FORCE COUNT WAS OUT OF SPECIFICATIONS; THE SENSOR WAS REMOVED AND THE RESISTANCE WAS FOUND TO BE ABOVE SPECIFICATIONS. A DIMPLED FORCE SENSOR SHIM AND PLATE WERE OBSERVED AND GREEN CONTAMINATION WAS LOCATED UNDER THE SHIM PLATE. IN CONCLUSION, THE PUMP WAS RETURNED IN POORLY MAINTAINED CONDITION WITH VARIOUS AREAS PHYSICALLY DAMAGED. THE PUMP WAS ALSO FOUND TO HAVE A DAMAGED FORCE SENSOR. HOWEVER, ALL PUMP INSULIN DELIVERY AND ALARM FUNCTIONS WERE FOUND TO BE FUNCTIONING WITHIN REQUIRED SPECIFICATIONS. THE COMPLAINT THAT THE PUMP CONTRIBUTED TO BLOOD GLUCOSE EXCURSIONS OR THAT THE PUMP HAD ISSUES WITH RANDOM ALARMS COULD NOT BE CONFIRMED. (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE DISTRIBUTOR REPORTED THAT THE PATIENT ALLEGED A DECLINE IN HEALTH SINCE GOING ON THE PUMP. IT WAS SAID THAT THE PATIENT WAS A VIGILANT TESTER OF BLOOD GLUCOSE LEVELS, AND THAT THE BLOOD GLUCOSE RESULTS INDICATED THAT INSULIN WAS NOT BEING DELIVERED ACCURATELY BY THE PUMP. IT WAS ALLEGED THAT THE PATIENT HAS MANY CONDITIONS RELATED TO POOR DIABETES CONTROL SUCH AS NERVE DAMAGE, HEART AND KIDNEY DISEASE, AND EYE DAMAGE. NO BLOOD GLUCOSE READINGS WERE PROVIDED AND NO SPECIFIC INCIDENCES OF HYPERGLYCEMIA OR HYPOGLYCEMIA WERE REPORTED. AT THE SAME TIME, IT WAS REPORTED THAT THE PUMP PRODUCED AN ALARM FOR NO REASON. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAINT IS BEING REPORTED BECAUSE A FORCE SENSOR ISSUE WAS DISCOVERED DURING INVESTIGATION. THERE WAS NO ALLEGATION OF A FORCE SENSOR ISSUE BY THE REPORTER AND NO INDICATION THAT THE ISSUE WAS RELATED TO AN ADVERSE EVENT. SEE MANUFACTURER'S NARRATIVE FOR DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222858 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1