BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 20565872 · Received October 30, 2024

    Report

    Report Number
    3016438761-2024-00634
    Event Type
    Malfunction
    Date Received
    October 30, 2024
    Date of Event
    October 16, 2024
    Report Date
    November 22, 2024
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137380
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. SECTION A1 PATIENT IDENTIFIER SIDS: (B)(6).

    Additional Manufacturer Narrative · 0

    ABBOTT FIELD SERVICE (FS) INVESTIGATED THE ISSUE ON SITE. FS TROUBLESHOOTING INCLUDED REPLACING THE R1 ALINITY C-SERIES REAGENT PROBE WHICH RESOLVED THE ISSUE. THERE HAVE BEEN NO FURTHER REPORTS OF DISCREPANT RESULTS SINCE THE PART WAS REPLACED. A REVIEW OF THE ALINITY C PROCESSING MODULE SN # (B)(6) SERVICE HISTORY WAS NOT ABLE TO IDENTIFY OR CONFIRM ANY ADDITIONAL LIKELY CAUSES. A REVIEW OF HISTORICAL DATA REVEALED NO TRENDS, SYSTEMIC ISSUES, OR RELATED NONCONFORMANCES. A REVIEW OF THE CLINICAL CHEMISTRY SYSTEMS REVEALED FOUND NO SYSTEMIC ISSUES OR TRENDS FOR THE ISSUE ASSOCIATED WITH THIS TICKET (ERRATIC/DISCREPANT RESULTS). A REVIEW OF LABELLING ADEQUATELY ADDRESSES SAMPLE RESULTS OBSERVED PROBLEMS FOR ERRATIC / DISCREPANT RESULTS. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ALINITY C PROCESSING MODULE SN# (B)(6)

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED SODIUM AND POTASSIUM RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE ON TWO PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED: SID: (B)(6), SODIUM = 162 / 140 MMOL/L; POTASSIUM = 7.2 / 4.6 MMOL/L, SID: (B)(6), SODIUM = 191 / 139 MMOL/L; POTASSIUM = > 10.0 / 4.7 MMOL/L, (NORMAL RANGES: SODIUM: 133 ¿ 146 MMOL/L; POTASSIUM: 3.5 - 5.3 MMOL/L). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED SODIUM AND POTASSIUM RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE ON TWO PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6) SODIUM = 162 / 140 MMOL/L; POTASSIUM = 7.2 / 4.6 MMOL/L SID (B)(6) SODIUM = 191 / 139 MMOL/L; POTASSIUM = > 10.0 / 4.7 MMOL/L (NORMAL RANGES: SODIUM: 133 ¿ 146 MMOL/L; POTASSIUM: 3.5 - 5.3 MMOL/L) NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1020414 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALNTY C ICT SAMPLE DILU, 07P53-20,| ALNTY C ICT SAMPLE DILU, 07P53-20,