BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C TOTAL BILIRUBIN REAGENT KIT

    MDR report key: 21166700 · Received January 16, 2025

    Report

    Report Number
    3002809144-2025-00009
    Event Type
    Malfunction
    Date Received
    January 16, 2025
    Date of Event
    December 30, 2024
    Report Date
    February 7, 2025
    Manufacturer
    ABBOTT GMBH
    Product Code
    CIG
    UDI-DI
    00380740158422
    PMA / PMN Number
    K121985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVALUATION OF COMPLAINT DATA FOR THE PRODUCT AND LIKELY CAUSE ALINITY C TOTAL BILIRUBIN REAGENT LOT 66829UQ08 IDENTIFIED NORMAL COMPLAINT ACTIVITY AND THERE ARE NO TRENDS FOR THE PRODUCT RELATED TO PATIENT RESULTS. NO CUSTOMER RETURNS WERE AVAILABLE FOR EVALUATION. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE LOT DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. THE PERFORMANCE OF THE LIKELY CAUSE LOT WAS INVESTIGATED BY COMPLETING A REVIEW FOR NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES AND DEVIATIONS RELATED TO THE LIKELY CAUSE LOT. THIS REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES OR DEVIATIONS. A REVIEW OF LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY FOR THE ALINITY C TOTAL BILIRUBIN WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    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. SECTION A1 PATIENT IDENTIFIER SIDS: (B)(6).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED TOTAL BILIRUBIN RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE ON MULTIPLE PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED: SID DATE TIME INITIAL / REPEAT (ANOTHER ALINITY) (B)(6), (B)(6)2024 20:24 16.0 MG/DL; RETEST 1.2 MG/DL, (B)(6), (B)(6) 2024 20:12 3.9 MG/DL; RETEST 0.3 MG/DL, (B)(6), (B)(6)2024 20:01 3.9 MG/DL; RETEST 0.3 MG/DL, (B)(6), (B)(6) 2024 20:00 4.4 MG/DL; RETEST 0.5 MG/DL, (B)(6), (B)(6) 2024 19:59 7.1 MG/DL; RETEST 0.6 MG/DL, (B)(6), (B)(6) 2024 19:45 15.0 MG/DL; RETEST 2.1 MG/DL, (B)(6), (B)(6) 2024 19:43 7.2 MG/DL; RETEST 0.9 MG/DL, (B)(6), (B)(6) 2024 19:35 7.5 MG/DL; RETEST 0.9 MG/DL, (B)(6), (B)(6) 2024 19:25 14.4 MG/DL; RETEST 1.2 MG/DL, (B)(6), (B)(6) 2024 19:24 4.9 MG/DL; RETEST 0.4 MG/DL, (B)(6), (B)(6) 2024 18:59 5.6 MG/DL; RETEST 0.3 MG/DL, (B)(6), (B)(6) 2024 18:54 5.8 MG/DL; RETEST 0.7 MG/DL, (B)6), (B)(6) 2024 18:43 6.4 MG/DL; RETEST 0.6 MG/DL, (B)(6), (B)(6) 2024 17:42 6.2 MG/DL; RETEST 0.6 MG/DL, (B)(6), (B)(6) 2024 17:41 3.9 MG/DL; RETEST 0.4 MG/DL, (B)(6), (B)(6) 2024 17:29 5.8 MG/DL; RETEST 0.5 MG/DL, (B)(6), (B)(6) 2024 17:22 >25.0 MG/DL; RETEST 6.7 MG/DL, (B)(6), (B)(6) 2024 17:19 4.6 MG/DL; RETEST 0.6 MG/DL, (B)(6), (B)(6) 2024 17:14 8.0 MG/DL; RETEST 0.8 MG/DL, (B)(6), (B)(6)2024 17:13 5.2 MG/DL; RETEST 0.4 MG/DL, (B)(6), (B)(6)2024 17:11 4.5 MG/DL; RETEST 0.4 MG/DL, (B)(6), (B)(6)2024 17:07 5.3 MG/DL; RETEST 0.5 MG/DL, (B)(6), (B)(6)2024 16:39 4.9 MG/DL; RETEST 0.3 MG/DL (B)(6), (B)(6)2024 16:39 3.7 MG/DL; RETEST 0.3 MG/DL, REFERENCE RANGE: 18 YR - 150 (0 - 1.2 MG/DL) , NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED TOTAL BILIRUBIN RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE ON MULTIPLE PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED: SID DATE TIME INITIAL / REPEAT (ANOTHER ALINITY) (B)(6), ON (B)(6) 2024, 20:24 16.0 MG/DL; RETEST 1.2 MG/DL, (B)((6), ON (B)(6) 2024, 20:12 3.9 MG/DL; RETEST 0.3 MG/DL, (B)(6), ON (B)(6) 2024, 20:01 3.9 MG/DL; RETEST 0.3 MG/DL, (B)(6), ON (B)(6) 2024, 20:00 4.4 MG/DL; RETEST 0.5 MG/DL, (B)(6), ON (B)(6) 2024, 19:59 7.1 MG/DL; RETEST 0.6 MG/DL, (B)(6), ON (B)(6) 2024, 19:45 15.0 MG/DL; RETEST 2.1 MG/DL, (B)(6), ON (B)(6) 2024, 19:43 7.2 MG/DL; RETEST 0.9 MG/DL, (B)(6), ON (B)(6) 2024, 19:35 7.5 MG/DL; RETEST 0.9 MG/DL, (B)(6), ON (B)(6) 2024, 19:25 14.4 MG/DL; RETEST 1.2 MG/DL, (B)(6), ON (B)(6) 2024, 19:24 4.9 MG/DL; RETEST 0.4 MG/DL, (B)(6), ON (B)(6) 2024, 18:59 5.6 MG/DL; RETEST 0.3 MG/DL, (B)(6), ON (B)(6) 2024, 18:54 5.8 MG/DL; RETEST 0.7 MG/DL, (B)(6), ON (B)(6) 2024, 18:43 6.4 MG/DL; RETEST 0.6 MG/DL, (B)(6), ON (B)(6) 2024, 17:42 6.2 MG/DL; RETEST 0.6 MG/DL, (B)(6), ON (B)(6) 2024, 17:41 3.9 MG/DL; RETEST 0.4 MG/DL, (B)(6), ON (B)(6) 2024, 17:29 5.8 MG/DL; RETEST 0.5 MG/DL, (B)(6), ON (B)(6) 2024, 17:22 >25.0 MG/DL; RETEST 6.7 MG/DL, (B)(6), ON (B)(6) 2024, 17:19 4.6 MG/DL; RETEST 0.6 MG/DL, (B)(6), ON (B)(6) 2024, 17:14 8.0 MG/DL; RETEST 0.8 MG/DL, (B)(6), ON (B)(6) 2024, 17:13 5.2 MG/DL; RETEST 0.4 MG/DL, (B)(6), ON (B)(6) 2024, 17:11 4.5 MG/DL; RETEST 0.4 MG/DL, (B)(6), ON (B)(6) 2024, 17:07 5.3 MG/DL; RETEST 0.5 MG/DL, (B)(6), ON (B)(6) 2024, 16:39 4.9 MG/DL; RETEST 0.3 MG/DL, (B)(6), ON (B)(6) 2024, 16:39 3.7 MG/DL; RETEST 0.3 MG/DL, REFERENCE RANGE: 18 YR - 150 (0 - 1.2 MG/DL) . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757733 ALINITY C TOTAL BILIRUBIN REAGENT KIT DIAZO COLORIMETRY, BILIRUBIN CIG ABBOTT GMBH 66829UQ08 00380740158422

    Patients

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