BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000

    MDR report key: 17583210 · Received August 21, 2023

    Report

    Report Number
    3016438761-2023-00430
    Event Type
    Malfunction
    Date Received
    August 21, 2023
    Date of Event
    July 21, 2023
    Report Date
    August 29, 2023
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740005924
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IN SECTION B5 AND H10 (A1 PATIENT IDENTIFIER) AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. COMPLETED INFORMATION IN SECTION A1 PATIENT IDENTIFIER: (B)(6). ADDITIONAL SIDS PROVIDED ON 04AUG2023: (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE INSTRUMENT AND DETERMINED THE AERO CUVETTE PR DRY AND ICT REFERENCE CUP, (ROHS) THE LIKELY CAUSES OF THE ISSUE, AS THE AERO CUVETTE PR DRY WAS WORN AND THE ICT REFERENCE CUP, (ROHS) WAS LEAKING. THE PARTS WERE REPLACED, AND THE ISSUE WAS RESOLVED. NO ADDITIONAL DISCREPANT RESULT ISSUES HAVE BEEN REPORTED SINCE THE SERVICE ACTIVITY WAS COMPLETED. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. THE INSTRUMENT SERVICE HISTORY REVIEW REVEALED THERE WERE NO ADDITIONAL SERVICE OR COMPLAINT ISSUES ON OR AROUND THE DATE THIS COMPLAINT WAS INITIATED THAT MAY HAVE CONTRIBUTED TO THIS ISSUE. A REVIEW OF TRACKING AND TRENDING OF THE ARCHITECT C16000 PROCESSING MODULE DID NOT IDENTIFY ANY TRENDS FOR THE COMPLAINT ISSUE. A REVIEW OF THE SCORECARD IDENTIFIED NO SIMILAR ISSUES RELATED TO THE ARCHITECT C16000 PROCESSING MODULE OR LIKELY CAUSE PARTS AS DESCRIBED. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY FOR THE ARCHITECT C16000 PROCESSING MODULE SERIAL NUMBER (B)(6) OR THE AERO CUVETTE PR DRY AND ICT REFERENCE CUP, (ROHS) WAS IDENTIFIED. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. CORRECTED INFORMATION IN SECTION H4 - DEVICE MFG DATE.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. COMPLETED INFORMATION IN SECTION A1 PATIENT IDENTIFIER: (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED SODIUM AND POTASSIUM RESULTS GENERATED ON THE ARCTHITECT C16000 PROCESSING MODULE FOR MULTIPLE SAMPLES. (CUSTOMER PROVIDED REFERENCE RANGES: (SODIUM REFERENCE RANGE 137-146 MMOL/L)(POTASSIUM REFERENCE RANGE 3.5-5.0 MMOL/L) SODIUM RESULTS = 103 AND 108, REPEAT RESULTS IN THE NORMAL RANGE POTASSIUM INITIAL RESULT = 2.4 MMOL/L, REPEAT RESULT IN THE NORMAL RANGE SODIUM INITIAL RESULT = 116 MMOL/L, REPEAT 142 MMOL/L 21JUL2023 SID (B)(6) INITIAL SODIUM RESULT = 102 MMOL/L, REPEAT RESULT = 141 MMOL/L 23JUL2023 SID (B)(6) INITIAL SODIUM RESULT = 107 MMOL/L, REPEAT RESULT = 145 MMOL/L 24JUL2023 SID (B)(6) INITIAL SODIUM RESULT = 100 MMOL/L, REPEAT RESULT = 137 MMOL/L 24JUL2023 SID (B)(6) INITIAL SODIUM RESULT = 101 MMOL/L, REPEAT RESULT = 139 MMOL/L 24JUL2023 SID (B)(6) INITIAL SODIUM RESULT = 101 MMOL/L, REPEAT RESULT = 138 MMOL/L 24JUL2023 SID (B)(6) INITIAL SODIUM RESULT = 102 MMOL/L, REPEAT RESULT = 140 MMOL/L 24JUL2023 SID (B)(6) INITIAL SODIUM RESULT = 104 MMOL/L, REPEAT RESULT = 139 MMOL/L 24JUL2023 SID (B)(6) INITIAL SODIUM RESULT = 103 MMOL/L, REPEAT RESULT = 140 MMOL/L 24JUL2023 SID (B)(6) INITIAL SODIUM RESULT = 101 MMOL/L, REPEAT RESULT = 139 MMOL/L 24JUL2023 SID (B)(6) INITIAL SODIUM RESULT = 105 MMOL/L, REPEAT RESULT = 142 MMOL/L 24JUL2023 SID (B)(6) INITIAL SODIUM RESULT = 101 MMOL/L, REPEAT RESULT = 141 MMOL/L 24JUL2023 SID (B)(6) INITIAL SODIUM RESULT = 102 MMOL/L, REPEAT RESULT = 137 MMOL/L 24JUL2023 SID (B)(6) INITIAL SODIUM RESULT = 103 MMOL/L, REPEAT RESULT = 140 MMOL/L 24JUL2023 SID (B)(6) INITIAL SODIUM RESULT = 104 MMOL/L, REPEAT RESULT = 142 MMOL/L RESULTS AFTER WORKING ON INSTRUMENT: 24JUL2023 SID (B)(6) INITIAL SODIUM RESULT = 100 MMOL/L, REPEAT RESULTS = 137 MMOL/L RESULTS AFTER ICT MODULE WAS REPLACED: 24JUL2023 SID (B)(6) INITIAL SODIUM RESULT = 109 MMOL/L, REPEAT SODIUM RESULT = 137 MMOL/L, INITIAL POTASSIUM RESULT = 2.3 MMOL/L, REPEAT POTASSIUM RESULT = 4.3 MMOL/L ADDITIONALLY, THE CUSTOMER REPORTED ON 26JUL2023 A PATIENT WAS ADMITTED TO THE EMERGENCY ROOM WITH THE LOW SODIUM RESULT. SID (B)(6) SODIUM 101 MMOL/L, REPEAT RESULT 141 MMOL/L ADDITIONAL LAB DATA PROVIDED FOR THE PATIENT: POTASSIUM 3.5 MMOL/L, REPEAT RESULT 4.8 MMOL/L, CHLORIDE 93 MMOL/L, REPEAT RESULT 107 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. UPDATE: ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER ON 04AUG2023. THE FOLLOWING INFORMATION WAS PROVIDED: 31JUL2023 SID (B)(6) INITIAL SODIUM RESULT = 116 MMOL/L, REPEAT = 142 MMOL/L. 01AUG2023 SID (B)(6) INITIAL SODIUM RESULT = 112 MMOL/L, REPEAT = 138 MMOL/L. 01AUG2023 SID (B)(6) INITIAL SODIUM RESULT = 114 MMOL/L, REPEAT = 140 MMOL/L. 02AUG2023 SID (B)(6) INITIAL SODIUM RESULT = 118 MMOL/L, REPEAT = 140 MMOL/L. 02AUG2023 SID (B)(6) INITIAL SODIUM RESULT = 107 MMOL/L, REPEAT = 141 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED SODIUM AND POTASSIUM RESULTS GENERATED ON THE ARCTHITECT C16000 PROCESSING MODULE FOR MULTIPLE SAMPLES. (CUSTOMER PROVIDED REFERENCE RANGES: (SODIUM REFERENCE RANGE 137-146 MMOL/L)(POTASSIUM REFERENCE RANGE 3.5-5.0 MMOL/L). SODIUM RESULTS = 103 AND 108, REPEAT RESULTS IN THE NORMAL RANGE. POTASSIUM INITIAL RESULT = 2.4 MMOL/L, REPEAT RESULT IN THE NORMAL RANGE. SODIUM INITIAL RESULT = 116 MMOL/L, REPEAT 142 MMOL/L.. (B)(6) 2023 SID (B)(6) INITIAL SODIUM RESULT = 102 MMOL/L, REPEAT RESULT = 141 MMOL/L. (B)(6) 2023 SID (B)(6) INITIAL SODIUM RESULT = 107 MMOL/L, REPEAT RESULT = 145 MMOL/L. (B)(6) 2023 SID (B)(6) INITIAL SODIUM RESULT = 100 MMOL/L, REPEAT RESULT = 137 MMOL/L. (B)(6) 2023 SID (B)(6) INITIAL SODIUM RESULT = 101 MMOL/L, REPEAT RESULT = 139 MMOL/L. (B)(6) 2023 SID (B)(6) INITIAL SODIUM RESULT = 101 MMOL/L, REPEAT RESULT = 138 MMOL/L. (B)(6) 2023 SID (B)(6) INITIAL SODIUM RESULT = 102 MMOL/L, REPEAT RESULT = 140 MMOL/L. (B)(6) 2023 SID (B)(6) INITIAL SODIUM RESULT = 104 MMOL/L, REPEAT RESULT = 139 MMOL/L. (B)(6) 2023 SID (B)(6) INITIAL SODIUM RESULT = 103 MMOL/L, REPEAT RESULT = 140 MMOL/L. (B)(6) 2023 SID (B)(6) INITIAL SODIUM RESULT = 101 MMOL/L, REPEAT RESULT = 139 MMOL/L. (B)(6) 2023 SID (B)(6) INITIAL SODIUM RESULT = 105 MMOL/L, REPEAT RESULT = 142 MMOL/L. (B)(6) 2023 SID (B)(6) INITIAL SODIUM RESULT = 101 MMOL/L, REPEAT RESULT = 141 MMOL/L. (B)(6) 2023 SID (B)(6) INITIAL SODIUM RESULT = 102 MMOL/L, REPEAT RESULT = 137 MMOL/L. (B)(6) 2023 SID (B)(6) INITIAL SODIUM RESULT = 103 MMOL/L, REPEAT RESULT = 140 MMOL/L. (B)(6) 2023 SID (B)(6) INITIAL SODIUM RESULT = 104 MMOL/L, REPEAT RESULT = 142 MMOL/L. RESULTS AFTER WORKING ON INSTRUMENT: (B)(6) 2023 SID (B)(6) INITIAL SODIUM RESULT = 100 MMOL/L, REPEAT RESULTS = 137 MMOL/L. RESULTS AFTER ICT MODULE WAS REPLACED: (B)(6) 2023 SID (B)(6) INITIAL SODIUM RESULT = 109 MMOL/L, REPEAT SODIUM RESULT = 137 MMOL/L, INITIAL POTASSIUM RESULT = 2.3 MMOL/L, REPEAT POTASSIUM RESULT = 4.3 MMOL/L. ADDITIONALLY, THE CUSTOMER REPORTED ON 26JUL2023 A PATIENT WAS ADMITTED TO THE EMERGENCY ROOM WITH THE LOW SODIUM RESULT. SID (B)(6) SODIUM 101 MMOL/L, REPEAT RESULT 141 MMOL/L. ADDITIONAL LAB DATA PROVIDED FOR THE PATIENT: POTASSIUM 3.5 MMOL/L, REPEAT RESULT 4.8 MMOL/L, CHLORIDE 93 MMOL/L, REPEAT RESULT 107 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. UPDATE: ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER ON 04AUG2023. THE FOLLOWING INFORMATION WAS PROVIDED: (B)(6) 2023 SID (B)(6) INITIAL SODIUM RESULT = 116 MMOL/L, REPEAT = 142 MMOL/L. (B)(6) 2023 SID (B)(6) INITIAL SODIUM RESULT = 112 MMOL/L, REPEAT = 138 MMOL/L. (B)(6) 2023 SID (B)(6) INITIAL SODIUM RESULT = 114 MMOL/L, REPEAT = 140 MMOL/L. (B)(6) 2023 SID (B)(6) INITIAL SODIUM RESULT = 118 MMOL/L, REPEAT = 140 MMOL/L. (B)(6) 2023 SID (B)(6) INITIAL SODIUM RESULT = 107 MMOL/L, REPEAT = 141 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED SODIUM AND POTASSIUM RESULTS GENERATED ON THE ARCTHITECT C16000 PROCESSING MODULE FOR MULTIPLE SAMPLES. (CUSTOMER PROVIDED REFERENCE RANGES: (SODIUM REFERENCE RANGE 137-146 MMOL/L)(POTASSIUM REFERENCE RANGE 3.5-5.0 MMOL/L) SODIUM RESULTS = 103 AND 108, REPEAT RESULTS IN THE NORMAL RANGE POTASSIUM INITIAL RESULT = 2.4 MMOL/L, REPEAT RESULT IN THE NORMAL RANGE SODIUM INITIAL RESULT = 116 MMOL/L, REPEAT 142 MMOL/L (B)(6) 2023 SID (B)(6) INITIAL SODIUM RESULT = 102 MMOL/L, REPEAT RESULT = 141 MMOL/L. (B)(6) 2023 SID (B)(6) INITIAL SODIUM RESULT = 107 MMOL/L, REPEAT RESULT = 145 MMOL/L. (B)(6) 2023 SID (B)(6) INITIAL SODIUM RESULT = 100 MMOL/L, REPEAT RESULT = 137 MMOL/L. (B)(6) 2023 SID (B)(6) INITIAL SODIUM RESULT = 101 MMOL/L, REPEAT RESULT = 139 MMOL/L. (B)(6) 2023 SID (B)(6) INITIAL SODIUM RESULT = 101 MMOL/L, REPEAT RESULT = 138 MMOL/L. (B)(6) 2023 SID (B)(6) INITIAL SODIUM RESULT = 102 MMOL/L, REPEAT RESULT = 140 MMOL/L. (B)(6) 2023 SID (B)(6) INITIAL SODIUM RESULT = 104 MMOL/L, REPEAT RESULT = 139 MMOL/L. (B)(6) 2023 SID (B)(6) INITIAL SODIUM RESULT = 103 MMOL/L, REPEAT RESULT = 140 MMOL/L. (B)(6) 2023 SID (B)(6) INITIAL SODIUM RESULT = 101 MMOL/L, REPEAT RESULT = 139 MMOL/L. (B)(6) 2023 SID (B)(6) INITIAL SODIUM RESULT = 105 MMOL/L, REPEAT RESULT = 142 MMOL/L. (B)(6) 2023 SID (B)(6) INITIAL SODIUM RESULT = 101 MMOL/L, REPEAT RESULT = 141 MMOL/L. (B)(6) 2023 SID (B)(6) INITIAL SODIUM RESULT = 102 MMOL/L, REPEAT RESULT = 137 MMOL/L. (B)(6) 2023 SID (B)(6) INITIAL SODIUM RESULT = 103 MMOL/L, REPEAT RESULT = 140 MMOL/L. (B)(6) 2023 SID (B)(6) INITIAL SODIUM RESULT = 104 MMOL/L, REPEAT RESULT = 142 MMOL/L. RESULTS AFTER WORKING ON INSTRUMENT: (B)(6) 2023 SID (B)(6) INITIAL SODIUM RESULT = 100 MMOL/L, REPEAT RESULTS = 137 MMOL/L. RESULTS AFTER ICT MODULE WAS REPLACED: (B)(6) 2023 SID (B)(6) INITIAL SODIUM RESULT = 109 MMOL/L, REPEAT SODIUM RESULT = 137 MMOL/L, INITIAL POTASSIUM RESULT = 2.3 MMOL/L, REPEAT POTASSIUM RESULT = 4.3 MMOL/L. ADDITIONALLY, THE CUSTOMER REPORTED ON (B)(6) 2023 A PATIENT WAS ADMITTED TO THE EMERGENCY ROOM WITH THE LOW SODIUM RESULT. SID (B)(6) SODIUM 101 MMOL/L, REPEAT RESULT 141 MMOL/L ADDITIONAL LAB DATA PROVIDED FOR THE PATIENT: POTASSIUM 3.5 MMOL/L, REPEAT RESULT 4.8 MMOL/L, CHLORIDE 93 MMOL/L, REPEAT RESULT 107 MMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1785783 ARCHITECT C16000 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740005924

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown AERO CUV PR DRY, 09D33-03, UNKNOWN| ICT REFERENCE CUP, (ROHS), (B)(6), UNKNOWN