BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INPECO SYSTEM

    MDR report key: 2180279 · Received July 27, 2011

    Report

    Report Number
    3002809144-2011-00524
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 15, 2011
    Manufacturer
    ABBOTT GERMANY
    Product Code
    JQP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE PRESENTATION AND SAMPLE QUEUE ERRORS (SPE/SQE) ARE OCCURRING ON THE ACCELERATOR APS (AUTOMATED PROCESSING SYSTEM) AT AN ATTACHED ARCHITECT C16000. THE LOGS SHOW THAT CARRIERS WERE PUSHED PAST THE SAMPLE GATE PRIOR TO SAMPLE ASPIRATION. AFTER THE ASPIRATION FROM A SAMPLE TUBE BEGINS, MULTIPLE CARRIERS MAY HAVE PASSED DURING THE ASPIRATION TIME. THE SYSTEM WILL FLAG THE INITIAL SAMPLE WITH A SAMPLE PRESENTATION ERROR AND THE SAMPLE AT THE GATE AT THE END OF THE ASPIRATION WITH A SAMPLE QUEUE ERROR, BUT ANY OTHER TUBE THAT PASSED UNDER THE PROBE BETWEEN THE BEGINNING AND END WOULD NOT BE FLAGGED WITH AN ERROR. THE ERROR SYSTEM WAS NOT DESIGNED FOR THE POSSIBLE OCCURRENCE OF MANY TUBES PASSING THROUGH A CLOSED GATE. IT WAS ALSO NOTED THAT THE MIDDLEWARE DID NOT FLAG THE SAMPLES THAT GENERATED THE ERROR. IT WAS DISCOVERED THAT MIDDLEWARE VENDOR (NON-ABBOTT) HAD TURNED OFF THE RULE WHILE PROVIDING TECHNICAL SUPPORT, BUT FAILED TO TURN IT BACK ON. ABBOTT FIELD SERVICE REPLACED AND ADJUSTED COMPONENTS (MICROMOTORS AND IM STOP GATES) OF THE INPECO SYSTEM TO ADDRESS THE ISSUE. REVIEW OF THE APS SOFTWARE CODE DETERMINED THAT THE SOFTWARE IS NOT PERFORMING AS EXPECTED AS IT DOES NOT IDENTIFY ALL SAMPLES IN SAMPLE PRESENTATION/SAMPLE QUEUE SCENARIOS WHEN MORE THAN TWO TUBES ARE INVOLVED. THE ISSUE IS EXPECTED TO BE RESOLVED IN A FUTURE VERSION OF APS SOFTWARE. AN ARCHITECT C SYSTEM DOES NOT WASH THE PROBE BETWEEN EACH ASPIRATION, ONLY BETWEEN SAMPLES; THEREFORE, SAMPLE COULD POTENTIALLY BECOME CONTAMINATED. THE OPERATOR MAY NOT BE AWARE THAT A SAMPLE COULD BE CONTAMINATED SINCE NO ERROR MESSAGE IS GENERATED. A PRODUCT DEFICIENCY OF THE SYSTEM HAS BEEN IDENTIFIED AS THE ISSUE MAY CAUSE SAMPLES TO BECOME CONTAMINATED WITHOUT AN ERROR CODE GENERATED TO WARN THE OPERATOR. COMPLAINT ACTIVITY WAS REVIEWED AND IDENTIFIED SIMILAR/RELATED COMPLAINTS IN ASSOCIATION WITH THE ISSUE CURRENTLY UNDER EVALUATION. THE ACCELERATOR APS OPERATIONS MANUAL (B)(4) CONTAINS INFORMATION TO HELP THE CUSTOMER TROUBLESHOOT THIS ISSUE. EVALUATION, METHOD: REVIEW OF COMPLAINT TRACKING AND TRENDING; FIELD SERVICE INTERVENTION.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT BETWEEN (B)(6) 2011 THE INPECO SYSTEM APS (AUTOMATED PROCESSING SYSTEM) HAS BEEN GENERATING SAMPLE PIPETTING AND SAMPLE QUEUE ERRORS (SPE AND SQE). TWENTY-FOUR ELECTROLYTE RESULTS WERE INCORRECTLY REPORTED FROM THE LAB DURING THIS TIME. THE RESULTS WERE DISCOVERED AND CORRECTED REPORTS SENT FROM THE LAB. NO INDIVIDUAL SPECIFIC PATIENT TESTING INFORMATION IS AVAILABLE. AN ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) SENT TO THE CUSTOMER SITE WAS ABLE TO RECREATE THE CUSTOMER'S ISSUE OF MULTIPLE SAMPLE CARRIERS BEING PUSHED PAST THE SAMPLE GATE. THE FSR SENT THREE DIFFERENT PATIENT SAMPLE TUBES THROUGH THE SYSTEM. THE APS PIPETTED THE FIRST TUBE AND THEN THE FSR LET THIS FIRST TUBE AND THE SECOND TUBE THROUGH THE SYSTEM, STOPPING AT THE THIRD TUBE. THE SYSTEM PIPETTED FROM THE THIRD TUBE AND ASSIGNED RESULTS TO THE SECOND TUBE. THE SYSTEM GENERATED AN SPE FOR THE SECOND TUBE AND AN SQE FOR THE THIRD TUBE. THE INCORRECT RESULTS WERE THEN SENT THROUGH THE LAB'S MIDDLEWARE, WHICH VALIDATED THE RESULTS WITHOUT ANY ERROR FLAGS OR MESSAGES. IN SUMMARY, ANY SAMPLE TUBE PASSING BETWEEN THE FIRST AND LAST SAMPLE ARE NOT BEING FLAGGED WITH AN ERROR. FOR SAMPLE ID (B)(6) THE FOLLOWING ASSAY WITH INITIAL AND RETEST RESULTS WERE PROVIDED: AST, 23 / 22 U/L; ALT, 24 / 33 U/L; CREATININE: 97.5 / 100 UMOL/L; LDL, 2.35 / 4.9 MMOLL; GGT, 81 / 22 U/L; UREA, 10.14 / 7.55 MMOL/L; UHDL, 1.50 / 1.6 MMOL/L; CHOLESTERL, 4.88 / 7.04 MMOL/L; AND TRIGLYCERIDES, 3.44 / 0.80 MMOL/L. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INPECO SYSTEM JQP ABBOTT GERMANY

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH C16000 ANALYZER LN: 3L77-01| ARCH C16000 ANALYZER LN: 3L77-01