BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1628664-2017-00368

    MDR report key: 6911988 · Received October 3, 2017

    Report

    Report Number
    1628664-2017-00368
    Event Type
    Malfunction
    Date Received
    October 3, 2017
    Date of Event
    September 10, 2017
    Report Date
    September 5, 2018
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    1628664-07/17/18-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A PRODUCT CORRECTION LETTER WAS ISSUED TO ALL ARCHITECT CLINICAL CHEMISTRY CUSTOMERS NOTIFYING THEM TO ADHERE TO THE LABELING INSTRUCTIONS LISTED IN THE ARCHITECT OPERATIONS MANUAL, SECTION 10, TO RESOLVE ERROR CODES 3580 TO 3585 OR 5381 BEFORE TRANSITIONING THE ARCHITECT TO THE RUNNING STATUS. THE PRODUCT CORRECTION LETTER PROVIDES GUIDANCE ON HOW THE CUSTOMER CAN ENSURE THE PRESSURE MONITORING SYSTEM IS FUNCTIONING AND ALSO RECOMMENDS FOLLOWING THE ARCHITECT SYSTEMS OPERATIONS MANUAL AND THE ASSAY-SPECIFIC DOCUMENTATION TO ENSURE ALL SAMPLES AND REAGENTS MEET DESCRIBED REQUIREMENTS BEFORE BEING PLACED ON THE ARCHITECT. THE INVESTIGATION FOUND THAT WHEN THE PRESSURE MONITOR BOARD COMMUNICATION ON THE ARCHITECT CLINICAL CHEMISTRY ANALYZER IS NOT SUCCESSFULLY ESTABLISHED DURING INITIAL INSTRUMENT BOOT UP, AND THE FOLLOWING ERROR CODES 3580 TO 3585 OR 5381 ARE NOT RESOLVED BY THE USER PRIOR TO TRANSITIONING THE ARCHITECT TO THE RUNNING STATUS, THERE IS THE POTENTIAL TO GENERATE INCORRECT RESULTS AS THE PRESSURE MONITORING SYSTEM IS INACTIVE. THE ARCHITECT SYSTEM SOFTWARE WILL BE UPDATED IN A FUTURE VERSION TO PREVENT THE ARCHITECT ANALYZER FROM TRANSITIONING TO THE RUNNING STATUS WHEN THE PRESSURE MONITORING SYSTEM IS IN AN ERROR STATE.

    Additional Manufacturer Narrative · 1

    LOCAL PHONE NUMBER CONTINUED: 912699 AN ABBOTT FIELD SERVICE ENGINEER (FSE) COMPLETED TROUBLESHOOTING OF THE INSTRUMENT. THIS INVOLVED REMOVAL AND CLEANING OF WASTE TUBING, WATER SHOCK TREATMENT TO THE WATERBATH AND SAMPLE AND SYRINGE TUBING WERE EVALUATED AND WERE DEEMED OK. CONTROLS AND PRECISION TESTING WAS COMPLETED AND THE INSTRUMENT WAS PUT BACK INTO SERVICE. REVIEW OF THE INSTRUMENT LOG REVIEW WAS COMPLETED; FROM (B)(6) TO (B)(6) 2017, THERE WERE 146 OCCURRENCES OF ERROR CODE 3375 (UNABLE TO PROCESS TEST, ASPIRATION ERROR OCCURRED.) TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND FOR THE CUSTOMER ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION NO PRODUCT DEFICIENCY OF THE ARCHITECT C16000 ANALYZER, LIST NUMBER 03L77, WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER GENERATED A FALSELY ELEVATED POTASSIUM RESULT WHILE USING THE ARCHITECT C16000 ANALYZER. THE CUSTOMER INDICATED SID 0683985H GENERATED AN INITIAL RESULT OF 6.8 AND A RETEST RESULT OF 4.9 MMOL/L THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT SOFTWARE V8.1 BASIC, LIST # 05F48-30| LIST # 05F48-30