BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C4000

    MDR report key: 15508801 · Received September 29, 2022

    Report

    Report Number
    3016438761-2022-00447
    Event Type
    Malfunction
    Date Received
    September 29, 2022
    Date of Event
    August 31, 2022
    Report Date
    October 19, 2022
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740003753
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ABBOTT FIELD SERVICE REPLACED THE ARCHITECT CUVETTE 1 PAIR (01G46-02) TO RESOLVE THE ISSUE. NO CONTRIBUTING FACTORS PRIOR TO THE COMPLAINT WERE IDENTIFIED IN REGARD TO THE SYSTEM. THE SERVICE HISTORY OF THE C401604 VERIFIES NO SUBSEQUENT DECREASED SODIUM, POTASSIUM AND CHLORIDE RESULTS HAVE BEEN REPORTED. TRENDING REVIEW DETERMINED NO ADVERSE TREND FOR THE ISSUE FOR THE PRODUCT. DEVICE HISTORY RECORD REVIEW DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES, OR DEVIATIONS. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO DEFICIENCY FOR THE C401604 ANALYZER WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. PATIENT IDENTIFIER SIDS: (B)(6) (18-DAY OLD MALE); (B)(6) (7-DAY OLD FEMALE); (B)(6) (2-YR OLD FEMALE); 1105903671 (3-MO. OLD MALE); (B)(6) (71-HR. OLD FEMALE).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY DECREASED SODIUM RESULTS GENERATED ON THE ARCHITECT C4000 ANALYZER ON MULTIPLE PATIENTS. RESULTS PROVIDED: (B)(6) 2022 SID: (B)(6) (18-DAY OLD MALE) = 114 MMOL/L, ANOTHER ARCHITECT = 141 MMOL/L (REFERENCE RANGE: 133-146 MMOL/L). (B)(6) 2022 SID: (B)(6) (7-DAY OLD FEMALE) = 119 / 138 MMOL/L (REFERENCE RANGE: 133-146 MMOL/L). (B)(6) 2022 SID: (B)(6) (2-YR OLD FEMALE) = 111 / 136 MMOL/L, ANOTHER ANALYZER = 137 MMOL/L (REFERENCE RANGE: 136-145 MMOL/L). (B)(6) 2022 SID: (B)(6) (3-MO. OLD MALE) = 107 MMOL/L, ANOTHER ARCHITECT = 141 MMOL/L (REFERENCE RANGE: 139-146 MMOL/L), OTHER RESULTS PROVIDED: POTASSIUM = 3.9 MMOL/L (REFERENCE RANGE: 3.4-6.0 MMOL/L), CHLORIDE = 92 MMOL/L (REFERENCE RANGE: 98-107 MMOL/L), ANOTHER ARCHITECT: POTASSIUM = 5.2 MMOL/L, CHLORIDE = 106 MMOL/L. (B)(6) 2022 SID: (B)(6) (71-HR. OLD FEMALE) = 105 MMOL/L, ANOTHER ARCHITECT = 138 MMOL/L (REFERENCE RANGE: 133-146 MMOL/L), OTHER RESULTS PROVIDED: POTASSIUM = 3.3 MMOL/L (REFERENCE RANGE: 3.2-5.5 MMOL/L), CHLORIDE = 96 MMOL/L (REFERENCE RANGE: 98-113 MMOL/L), ANOTHER ARCHITECT: POTASSIUM = 4.4 MMOL/L, CHLORIDE = 111 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1634044 ARCHITECT C4000 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 2P24-40 00380740003753

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CONC ICT DILUENT, 02P32-11, UNKNOWN.| CONC ICT DILUENT, 02P32-11, UNKNOWN.