BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 16737018 · Received April 13, 2023

    Report

    Report Number
    3016438761-2023-00205
    Event Type
    Malfunction
    Date Received
    April 13, 2023
    Date of Event
    April 9, 2023
    Report Date
    May 18, 2023
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137380
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER PERFORMED TROUBLESHOOTING, INCLUDING REPLACEMENT OF THE ICT MODULE AND PROBE WITH NO RESOLUTION AND SERVICE WAS DISPATCHED. SERVICE RESOLVED THE ISSUE BY REPLACING THE CABLE, ICT TO ICT PRE AMP ((B)(6)) ON THE ALINITY C PROCESSING MODULE, SERIAL NUMBER (B)(6). NO ADDITIONAL DISCREPANT RESULT ISSUES HAVE BEEN REPORTED SINCE THE SERVICE ACTIVITY WAS COMPLETED. THE CABLE, ICT TO ICT PRE AMP ((B)(6)) WAS DETERMINED TO BE THE LIKELY CAUSE OF THE ISSUE. THE INSTRUMENT SERVICE HISTORY REVIEW REVEALED NO ADDITIONAL SERVICE TICKETS ASSOCIATED WITH DISCREPANT/ERRATIC PATIENT RESULTS. THERE WERE NO ADDITIONAL SERVICE OR COMPLAINT ISSUES ON OR AROUND THE DATE THIS COMPLAINT WAS INITIATED THAT MAY HAVE CONTRIBUTED TO THIS ISSUE. THE TRACKING AND TRENDING OF DATA WAS REVIEWED AND DID NOT IDENTIFY ANY RELATED TRENDS FOR THE CABLE, ICT TO ICT PRE AMP ((B)(6)). THERE WERE NO SIMILAR ISSUES IDENTIFIED FOR THE ALINITY C PROCESSING MODULE. A DEVICE HISTORY RECORD WAS REVIEWED AND IDENTIFIED NO NON-CONFORMANCES OR DEVIATIONS FOR THE PART OR FOR THE INSTRUMENT ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE ISSUE UNDER REVIEW. BASED ON THE INFORMATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ALINITY C PROCESSING MODULE , SERIAL NUMBER (B)(6).

    Additional Manufacturer Narrative · 0

    A1- PATIENT IDENTIFIER: (B)(6) AND (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. 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 REPORTED FALSELY ELEVATED SODIUM (NA) RESULTS WHILE RUNNING ON THE ALINITY C PROCESSING MODULE. THE FOLLOWING DATA WAS PROVIDED: (B)(6): INITIAL NA = 165 MMOL/L; REPEATED ON ANOTHER ALINITY C PROCESSING MODULE ((B)(6)) = 142 MMOL/L (REFERENCE RANGE = 136-145 MMOL/L) (B)(6): SODIUM RESULTS: 164, 152, 133 MMOL/L (RAN ON (B)(6)) THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED, FALSELY ELEVATED SODIUM (NA) RESULTS WHILE RUNNING ON THE ALINITY C PROCESSING MODULE. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6): INITIAL NA. = 165 MMOL/L; REPEATED ON ANOTHER ALINITY C PROCESSING MODULE (AC05143) = 142 MMOL/L (REFERENCE RANGE = 136-145 MMOL/L). SID (B)(6): SODIUM RESULTS: 164,152,133 MMOL/L (RAN ON AC05142). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1249978 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 03R6701 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown