BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 13425946 · Received February 2, 2022

    Report

    Report Number
    3016438761-2022-00050
    Event Type
    Malfunction
    Date Received
    February 2, 2022
    Date of Event
    January 11, 2022
    Report Date
    March 18, 2022
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137380
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    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. PATIENT IDENTIFIER SIDS: (B)(6).

    Additional Manufacturer Narrative · 0

    ABBOTT FIELD SERVICE (FS) INVESTIGATED THE ISSUE ON SITE. FS TROUBLESHOOTING INCLUDED CORRECTING THE WASH HEAD TUBING WHICH WAS INCORRECTLY INSTALLED BY THE CUSTOMER. THIS RESOLVED THE ISSUE. THERE HAVE BEEN NO FURTHER REPORTS OF DISCREPANT RESULTS SINCE THE TUBING WAS REINSTALLED. A REVIEW OF THE ALINITY C 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 ANALYZER SN# (B)(6).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY DECREASED SODIUM AND CALCIUM RESULTS GENERATED ON THE ALINITY C ANALYZER ON MULTIPLE PATIENTS ON (B)(6) 2022. RESULTS PROVIDED: SID (B)(6): SODIUM = 100/ 145 / 143 MMOL/L, SID (B)(6): CALCIUM = 4.5 / 10.5 / 10.6 MG/DL, SID (B)(6): CALCIUM = 3.0 / 9.3 / 9.3 MG/DL, SID (B)(6): CALCIUM = 5.4 / 9.8 / 9.8 MG/DL, SID (B)(6): SODIUM = 114 / 139 / 143 MMOL/L, SID (B)(6): SODIUM = 118 / 143 MMOL/L; CALCIUM = 4.7 / 9.9 MG/DL, SID (B)(6): CALCIUM = 3.9 / 9.8 MG/DL. REFERENCE RANGES: SODIUM: 136-145 MMOL/L; CALCIUM: 8.4-10.2 MG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71851 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 03R6701 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ALNTY C CALCIUM RGT 400, 07P57-20, 49044UN21| ALNTY C CALCIUM RGT 400, 07P57-20, 49044UN21| ALNTY C ICT SAMPLE DILU, 07P53-20, 02358UN21| ALNTY C ICT SAMPLE DILU, 07P53-20, 02358UN21