BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 18636344 · Received February 2, 2024

    Report

    Report Number
    3016438761-2024-00068
    Event Type
    Malfunction
    Date Received
    February 2, 2024
    Date of Event
    January 23, 2024
    Report Date
    February 13, 2024
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137380
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. COMPLETED INFORMATION FOR SECTION A1 PATIENT IDENTIFICATION: SIDS (B)(6) SECTION E1 - PHONE COMPLETE ENTRY = (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    SECTION H4 - DEVICE MFG DATE UPDATED FROM BLANK TO 7/1/2019. THE FIELD SERVICE REPRESENTATIVE (FSR) PERFORMED TROUBLESHOOTING, INSPECTED THE INSTRUMENT, AND CLEANED THE CLOGGED NOZZLE C4 #1, #4, #5 WHICH RESOLVED THE ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. AN INSTRUMENT SERVICE HISTORY REVIEW REVEALED NO ADDITIONAL ERRATIC OR DISCREPANT PATIENT RESULTS REPORTED FOR (B)(6) . THERE WERE NO SERVICE OR COMPLAINT ISSUES ON OR AROUND THE DATE THIS COMPLAINT WAS INITIATED THAT MAY HAVE CONTRIBUTED TO THIS ISSUE. A REVIEW OF TRACKING AND TRENDING OF THE ALINITY C DID NOT IDENTIFY ANY TRENDS ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF TRACKING AND TRENDING FOR THE NOZZLE C4 #1, #4, #5 DID NOT IDENTIFY ANY TRENDS. DEVICE HISTORY RECORD REVIEW DID NOT SHOW ANY NON-CONFORMANCES OR POTENTIAL NON-CONFORMANCES FOR THE COMPLAINT ISSUE. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE AVAILABLE INFORMATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY C PROCESSING MODULE FOR SERIAL NUMBER (B)(6) OR THE NOZZLE C4 #1, #4, #5, WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY C TOTAL BILIRUBIN RESULTS FOR MULTIPLE PATIENTS. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE 5-25 MOL/L): SAMPLE ID (B)(6) INITIAL RESULT = 6.87 MOL/L, REPEAT RESULT ON ANOTHER INSTRUMENT (B)(6) = 4.48 MOL/L SAMPLE ID (B)(6) INITIAL RESULT = 5.67 MOL/L, REPEAT RESULT ON ANOTHER INSTRUMENT (B)(6) = 3.14 MOL/L SAMPLE ID (B)(6) INITIAL RESULT = 5.56 MOL/L, REPEAT RESULT ON ANOTHER INSTRUMENT (B)(6) = 3.53 MOL/L SAMPLE ID (B)(6) INITIAL RESULT = 7.02 MOL/L, REPEAT RESULT ON ANOTHER INSTRUMENT (B)(6) = 4.59 MOL/L SAMPLE ID (B)(6) INITIAL RESULT = 5.09 MOL/L, REPEAT RESULT ON ANOTHER INSTRUMENT (B)(6) = 2.76 MOL/L SAMPLE ID (B)(6) INITIAL RESULT = 5.83 MOL/L, REPEAT RESULT ON ANOTHER INSTRUMENT (B)(6) = 3.54 MOL/L SAMPLE ID (B)(6) INITIAL RESULT = 6.05 MOL/L, REPEAT RESULT ON ANOTHER INSTRUMENT (B)(6) = 3.58 MOL/L SAMPLE ID (B)(6) INITIAL RESULT = 5.87 MOL/L, REPEAT RESULT ON ANOTHER INSTRUMENT (B)(6) = 3.69 MOL/L SAMPLE ID (B)(6) INITIAL RESULT = 6.58 MOL/L, REPEAT RESULT ON ANOTHER INSTRUMENT (B)(6) = 4.26 MOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY C TOTAL BILIRUBIN RESULTS FOR MULTIPLE PATIENTS. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE 5-25 MOL/L): SAMPLE ID (B)(6) INITIAL RESULT = 6.87 MOL/L, REPEAT RESULT ON ANOTHER INSTRUMENT ((B)(6) ) = 4.48 MOL/L SAMPLE ID (B)(6) INITIAL RESULT = 5.67 MOL/L, REPEAT RESULT ON ANOTHER INSTRUMENT ((B)(6) ) = 3.14 MOL/L SAMPLE ID (B)(6) INITIAL RESULT = 5.56 MOL/L, REPEAT RESULT ON ANOTHER INSTRUMENT ((B)(6) ) = 3.53 MOL/L SAMPLE ID (B)(6) INITIAL RESULT = 7.02 MOL/L, REPEAT RESULT ON ANOTHER INSTRUMENT ((B)(6) ) = 4.59 MOL/L SAMPLE ID (B)(6) INITIAL RESULT = 5.09 MOL/L, REPEAT RESULT ON ANOTHER INSTRUMENT ((B)(6) ) = 2.76 MOL/L SAMPLE ID (B)(6) INITIAL RESULT = 5.83 MOL/L, REPEAT RESULT ON ANOTHER INSTRUMENT ((B)(6) ) = 3.54 MOL/ SAMPLE ID (B)(6) INITIAL RESULT = 6.05 MOL/L, REPEAT RESULT ON ANOTHER INSTRUMENT ((B)(6) ) = 3.58 MOL/L SAMPLE ID (B)(6) INITIAL RESULT = 5.87 MOL/L, REPEAT RESULT ON ANOTHER INSTRUMENT ((B)(6) ) = 3.69 MOL/L SAMPLE ID (B)(6) INITIAL RESULT = 6.58 MOL/L, REPEAT RESULT ON ANOTHER INSTRUMENT ((B)(6) ) = 4.26 MOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274181 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 TOTAL BILIRUBIN, 04V51-21, (B)(6) | ALNTY C TOTAL BILIRUBIN, 04V51-21, (B)(6)