BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 16174435 · Received January 16, 2023

    Report

    Report Number
    3016438761-2023-00022
    Event Type
    Malfunction
    Date Received
    January 16, 2023
    Report Date
    February 13, 2023
    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

    DURING THE REQUESTED SITE VISIT, THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE ANALYZER AND REPLACEMENT OF THE TUBING, PERISTALTIC HEAD (ROHS)_PART NUMBER 7-202464-0 LEAKING FROM THE CUVETTE WASH. THE REPLACEMENT OF PART TUBING, PERISTALTIC HEAD (ROHS) (7-202464-01), WHICH RESOLED THE ISSUE. A REVIEW OF THE ALINITY CI PROCESSING MODULE, SERIAL NUMBER (B)(6) SERVICE HISTORY WAS PERFORMED AND NO ADDITIONAL ERRATIC RESULTS PRE- OR POST THE CURRENT COMPLAINT WERE IDENTIFIED. A REVIEW OF TRACKING AND TRENDING OF THE ALINITY C PROCESSING MODULE DID NOT IDENTIFY ANY TRENDS ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS FOR THE TUBING, PERISTALTIC HEAD (ROHS). A REVIEW OF HISTORICAL DATA REVEALED NO TRENDS, SYSTEMIC ISSUES, OR RELATED NONCONFORMANCES. THE ALINITY CI-SERIES OPERATIONS MANUAL AND ALINITY C SERVICE DOCUMENTATION PROVIDE ADEQUATE INFORMATION REGARDING THE TROUBLESHOOTING OF ERRATIC/DISCREPANT RESULTS AND THE REMOVAL, REPLACEMENT AND VERIFICATION OF PART NUMBER 7-202464-01 TUBING, PERISTALTIC HEAD (ROHS). A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR EITHER THE ALINITY CI PROCESSING MODULE, SERIAL NUMBER (B)(6), OR THE TUBING, PERISTALTIC HEAD (ROHS).

    Additional Manufacturer Narrative · 0

    COMPLETE INFORMATION FOR SECTION A PATIENT INFORMATION, 1. PATIENT IDENTIFIER = SID= (B)(6) AND (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED SODIUM RESULTS ON ALINITY C PROCESSING MODULE FOR MULTIPLE PATIENTS. THE RESULTS PROVIDED WERE: SID (B)(6) INITIAL= 114 MMOL/L /REPEATED =137 MMOL/L. SID (B)(6) INITIAL=120 MMOL/L /REPEATED= 140 MMOL/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819186 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 03R6701 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown