BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCELERATOR APS

    MDR report key: 5330646 · Received December 28, 2015

    Report

    Report Number
    1628664-2015-00338
    Event Type
    Malfunction
    Date Received
    December 28, 2015
    Date of Event
    November 17, 2015
    Report Date
    February 4, 2016
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JQP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION WAS PERFORMED BY REVIEWING THE COMPLAINT TEXT, OTHER CUSTOMER COMPLAINTS FOR SIMILAR ISSUES, REVIEW OF LABELING, AND REVIEW OF HISTORICAL DATA. ERROR CODE 8276 SAMPLE PRESENTATION ERROR WAS REPORTED TO HAVE OCCURRED ON ARCHITECT SYSTEM (B)(4). REVIEW OF LOGS BY OMNILAB (MANUFACTURER OF THE AMS MIDDLEWARE) NOTED THAT ONE OF THE ARCHITECT INSTRUMENTS SENT ERROR 8276 FOR SAMPLE (B)(4), AND AMS RULES PROPERLY MANAGED THE ERROR. SAMPLE PRESENTATION (SPE) AND SAMPLE QUEUE (SQE) ERROR WAS GENERATED ON (B)(4) (FOLATE TEST) ON THE APS I2000SR INTERFACE MODULE A WEEK LATER. THE ERROR WAS SEEN IN THE AMS MIDDLEWARE ONLY, NO ERROR WAS FOUND IN THE MESSAGE HISTORY OF ARCHITECT (B)(4) OR IN THE APS HISTORY. WHEN A SAMPLE MOVES INTO POSITION FOR TESTING, THE SAMPLE CARRIER ID IS READ, TESTS ARE ASPIRATED, AND THE CARRIER ID IS READ AGAIN BEFORE THE SAMPLE IS RELEASED. IF THE INITIAL AND FINAL READS DO NOT MATCH, THE FIRST SAMPLE GENERATES THE PRESENTATION ERROR AND THE SECOND SAMPLE GENERATES THE QUEUE ERROR. THESE ERRORS ARE GENERATED BY THE APS SYSTEM. SAMPLE PRESENTATION ERRORS DUE TO ERROR CODE 8275 / 8276 ARE GENERATED BY THE ARCHITECT. THESE ERRORS OCCUR AS A RESULT OF ISSUES WITH THE COMMUNICATION BETWEEN THE APS AND ARCHITECT SYSTEMS. FIELD SERVICE REPLACED A MOTOR, PART NUMBER 8-203835-01, WHICH INTERMITTENTLY FORCED PUCKS PAST THE SAMPLE GATE TO ADDRESS THE ISSUE. NO ISSUES WITH THE APS COULD BE IDENTIFIED. THE RESULT LOG FOR ARCHITECT I2000SR SN (B)(4) CONFIRMED THAT (B)(4) WAS RUN ON (B)(6) 2015 AT 13:57 AND 18:10, NO ERROR MESSAGES WERE ASSOCIATED WITH THE SAMPLE AND NO ERRORS WERE FOUND IN THE HISTORY LOG. A REVIEW OF TICKET HISTORY FOR THE ANALYZER DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THE CURRENT COMPLAINT. THERE WAS NO TREND IDENTIFIED FOR MOTOR, PART NUMBER 8-203835-01, OR FOR THE APS SYSTEM RELATED TO THIS ISSUE. A REVIEW OF THE ARCHITECT AND APS OPERATIONS MANUALS DESCRIBES PROBABLE CAUSES AND CORRECTIVE ACTIONS FOR SPE AND SQE ERRORS. A REVIEW OF COMPLAINTS FOR THE OCCURRENCE OF SPE/SQE ERRORS OR ERROR CODE 8275/8276, FOUND THE ERRORS WERE ADDRESSED BY REPLACING OR ADJUSTING VARIOUS PARTS AND RERUNNING SAMPLES AS NECESSARY. BASED ON THE AVAILABLE INFORMATION, A DEFICIENCY WAS NOT IDENTIFIED. ERROR MESSAGES WERE PROPERLY GENERATED TO ALERT THE OPERATOR.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE ARCHITECT ANALYZER GENERATED SAMPLE PRESENTATION AND SAMPLE QUEUE ERRORS ON A PATIENT SAMPLE ((B)(4)) ON THE AMS (OMNILAB MIDDLEWARE) BUT NOT ON THE ARCHITECT ANALYZER. THE ARCHITECT TOOK SAMPLE FROM ONE TUBE WHILE A DIFFERENT TUBE WAS EXPECTED TO BE SAMPLED AND THE RESULTS DID NOT GO TO EXCEPTIONS. THE RESULTS GENERATED WERE FOR FOLATE - INITIAL 6.9 / REPEAT 3.3. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853642 ACCELERATOR APS AUTOMATED SAMPLE HANDLING AND PROCESSING SYSTEM JQP ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1