BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C TOTAL BILIRUBIN REAGENT KIT

    MDR report key: 20555639 · Received October 29, 2024

    Report

    Report Number
    3002809144-2024-00310
    Event Type
    Malfunction
    Date Received
    October 29, 2024
    Date of Event
    October 9, 2024
    Report Date
    November 15, 2024
    Manufacturer
    ABBOTT GMBH
    Product Code
    CIG
    UDI-DI
    00380740158422
    PMA / PMN Number
    K121985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, DEVICE HISTORY RECORD REVIEW AND LABELING REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. A SEARCH FOR SIMILAR COMPLAINTS DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR LOT 65669UQ01. A TICKET TRENDING REVIEW OF COMPLAINT LOT 65669UQ01 DID NOT IDENTIFY ANY RELATED TRENDS. A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES RELATED TO LOT NUMBER 65669UQ01 AND COMPLAINT ISSUE. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY C TOTAL BILIRUBIN REAGENT LOT NUMBER 65669UQ01 WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    COMPLETE ENTRY FOR SECTION A1 - PATIENT IDENTIFIER: (B)(6). 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.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY DEPRESSED TOTAL BILIRUBIN2 ON THE ALINITY C PROCESSING MODULE FOR ONE MALE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE < (B)(6): SID (B)(6), (B)(6) 2024, THE FIRST RUN OF THE SAMPLE GENERATED AN ERROR CODE OF 1041, REACTION CHECK FAILURE ON THE ALINITY SN (B)(6); WHEN REPEATED THE INITIAL BILIRUBIN RESULT= 2 UMOL/L. REPEAT TESTING ON THE ALINITY SN (B)(6) GENERATED THE ERROR CODE 1041 AGAIN; WHEN REPEATED, AFTER RECENTRIFUGATION, RESULTS= 200.1 UMOL/L AND 196.2 UMOL/L. ADDITIONAL RESULTS WERE PROVIDED FOR HISTORICAL/ ADDITIONAL COMPARISON: (B)(6) 2024= 204 UMOL/L, (B)(6) 2024= 209 UMOL/L, (B)(6) 2024= 218 UMOL/L, (B)(6) 2024= 246 UMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY DEPRESSED TOTAL BILIRUBIN2 ON THE ALINITY C PROCESSING MODULE FOR ONE MALE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE < 20 UMOL/L): SID (B)(6), . ON (B)(6) 2024, THE FIRST RUN OF THE SAMPLE GENERATED AN ERROR CODE OF 1041, REACTION CHECK FAILURE ON THE ALINITY SN (B)(6); WHEN REPEATED THE INITIAL BILIRUBIN RESULT= 2 UMOL/L. REPEAT TESTING ON THE ALINITY SN (B)(6) GENERATED THE ERROR CODE 1041 AGAIN; WHEN REPEATED, AFTER RECENTRIFUGATION, RESULTS= 200.1 UMOL/L AND 196.2 UMOL/L. ADDITIONAL RESULTS WERE PROVIDED FOR HISTORICAL/ ADDITIONAL COMPARISON: ON (B)(6) 2024= 204 UMOL/L. ON (B)(6) 2024= 209 UMOL/L. ON (B)(6) 2024= 218 UMOL/L. ON (B)(6) 2024= 246 UMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302447 ALINITY C TOTAL BILIRUBIN REAGENT KIT DIAZO COLORIMETRY, BILIRUBIN CIG ABBOTT GMBH 65669UQ01 00380740158422

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male ALNTY C PROCESSING MODU, 03R67-01, (B)(6)| ALNTY C PROCESSING MODU, 03R67-01, (B)(6)