BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000

    MDR report key: 10676501 · Received October 14, 2020

    Report

    Report Number
    3016438761-2020-00246
    Event Type
    Malfunction
    Date Received
    October 14, 2020
    Date of Event
    September 19, 2020
    Report Date
    November 19, 2020
    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

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PATIENT PROVIDED ON (B)(6) 2020: (B)(6) 2020 SID (B)(6): NA+ = 114 / 122 / 136 MMOL/L, REPEATED ON (B)(6) 2020 = 144 MMOL/L. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF TICKET TRENDING DID NOT IDENTIFY ANY COMPLAINTS THAT WERE SIMILAR FOR FALSELY DECREASED SODIUM, POTASSIUM AND CHLORIDE PATIENT RESULTS. THE TREND REVIEW BY THE PRODUCT LIST NUMBER FOUND NO TRENDS RELATED TO THIS ISSUE. A REVIEW OF THE ANALYZER (SN# (B)(6)) SERVICE HISTORY IDENTIFIED NO CONTRIBUTING FACTORS TO THE CURRENT COMPLAINT. A REVIEW OF THE CLINICAL CHEMISTRY SYSTEMS TRACKING AND TRENDING DATA REVEALED NO SYSTEMIC ISSUES OR TRENDS ASSOCIATED WITH THE DISCREPANT RESULTS DESCRIBED IN THIS COMPLAINT. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. PATIENT IDENTIFIER SID'S, AGE, GENDER: (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSELY DECREASED SODIUM (NA+), POTASSIUM (K+) AND CHLORIDE (CL-) RESULTS GENERATED ON THE ARCHITECT C16000 ON THREE PATIENTS. RESULTS PROVIDED: UOM = MMOL/L. ON (B)(6) 2020; MALE; (B)(6)-YRS OLD; SID: (B)(6): NA+ = < 100, ANOTHER ARCHITECT = 110, REPEATED ON (B)(6) 2020 = 141 / 142, ANOTHER ARCHITECT = 140/ 140/141; K+ = 3.4, ANOTHER ARCHITECT = 3.9 /, REPEATED ON (B)(6) 2020 = 5 / 5 , ANOTHER ARCHITECT = 4.9 / 4.9 / 5; CL- = 70, ANOTHER ARCHITECT = 82, REPEATED ON 22SEP2020 = 104/104, ANOTHER ARCHITECT = 103 / 104 / 103. ON (B)(6) 2020; FEMALE; (B)(6)-YRS OLD SID: (B)(6): NA+ = < 100, ANOTHER ARCHITECT = 118, REPEATED ON (B)(6) 2020 = 143 / 143, ANOTHER ARCHITECT = 142/ 142/143; K+ = 2.4, ANOTHER ARCHITECT = 2.9 /, REPEATED ON 22SEP2020 = 3.7 / 3.7 , ANOTHER ARCHITECT = 3.6 / 3.6 / 3.7; CL- = 70, ANOTHER ARCHITECT = 85, REPEATED ON 22SEP2020 = 102/102, ANOTHER ARCHITECT = 102 / 102 / 102. ON (B)(6) 2020; FEMALE; (B)(6)-YRS OLD; SID: (B)(6): NA+ = 103, ANOTHER ARCHITECT = 124, REPEATED ON (B)(6) 2020 = 141 / 141, ANOTHER ARCHITECT = 140/ 140/141; K+ = 4.1, ANOTHER ARCHITECT = 4.9 /, REPEATED ON (B)(6) 2020 = 5.5 / 5.5 , ANOTHER ARCHITECT = 5.5 / 5.5 / 5.5; CL- = 77, ANOTHER ARCHITECT = 92, REPEATED ON (B)(6) 2020 = 103/104, ANOTHER ARCHITECT = 103 / 104 / 103. REFERENCE RANGES: NA+ (137-146 MMOL/L), K+ (3.5-5.0 MMOL/L), CL- (102-111 MMOL/L). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1140643 ARCHITECT C16000 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 3L77-01 00380740005924

    Patients

    Seq Age Sex Outcome Treatment
    1