BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY C PROCESSING MODULE

    MDR report key: 16403500 · Received February 20, 2023

    Report

    Report Number
    3016438761-2023-00089
    Event Type
    Malfunction
    Date Received
    February 20, 2023
    Date of Event
    February 2, 2023
    Report Date
    March 31, 2023
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137380
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    BARRING THE SAMPLE BEING REPEATED, ADDITIONAL TROUBLESHOOTING WAS NOT PERFORMED BY THE CUSTOMER. SERVICE PERFORMED AN INSTRUMENT LOG ANALYSIS AND FOUND EVIDENCE OF R1 REAGENT ASPIRATION ERRORS (MESSAGE CODE 3012) FOR THE SAMPLES IN QUESTION. THE P. M. SENSOR WAS REPLACED AND DEEMED THE CAUSE OF THE ISSUE. NO CONTRIBUTING FACTORS IN THE MONTH PRIOR TO THE COMPLAINT WERE IDENTIFIED IN- REGARDS TO THE SYSTEM. THE SERVICE HISTORY OF THE (B)(6) VERIFIES NO SUBSEQUENT ISSUES HAVE BEEN REPORTED RELATED TO DISCREPANT RESULTS POST SERVICE INTERVENTION. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE ISSUE UNDER REVIEW. LABELING REVIEW CONCLUDES THAT THE ISSUE IS ADEQUATELY ADDRESSED. BASED ON THE INVESTIGATION, NO DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY C TOTAL BILIRUBIN RESULTS GENERATED ON THE ALINITY C PROCESSING MODULE. THE INSTRUMENT DID NOT GIVE ANY INSTRUMENT ERROR MESSAGES. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2023 INITIAL RESULT WAS 190 MMOL/L, AND THE RESULT AFTER THE RETEST ON (B)(6) 2023 WAS 35.7 MMOL/L (REFERENCE RANGE <22 MMOL/L). OTHER RESULTS PROVIDED: INITIAL RESULT 52 MMOL/L, REPEATED 9.1 MMOL/L; INITIAL RESULT 126.5 MMOL/L, REPEATED 16.6 MMOL/L; INITIAL RESULT 116.5 MMOL/L, REPEATED 16.1 MMOL/L; INITIAL RESULT 53.7 MMOL/L, REPEATED 9.01 MMOL/L; INITIAL RESULT 96.3 MMOL/L, REPEATED 5.1 MMOL/L; INITIAL RESULT 82 MMOL/L, REPEATED 15.1 MMOL/L; INITIAL RESULT 106.9 MMOL/L, REPEATED 16.5 MMOL/L; INITIAL RESULT 80.7 MMOL/L, REPEATED 13.4 MMOL/L; INITIAL RESULT 45.1 MMOL/L, REPEATED 6.5 MMOL/L; INITIAL RESULT 99.6 MMOL/L, REPEATED 17.7 MMOL/L; INITIAL RESULT 141.8 MMOL/L, REPEATED 20.7 MMOL/L; INITIAL RESULT 106.5 MMOL/L, REPEATED 18.9 MMOL/L; INITIAL RESULT 93.6 MMOL/L, REPEATED 14.9 MMOL/L; INITIAL RESULT 83.6 MMOL/L, REPEATED 14.6 MMOL/L; INITIAL RESULT 92.4 MMOL/L, REPEATED 13.2 MMOL/L; INITIAL RESULT 68.9 MMOL/L, REPEATED 8.3 MMOL/L; INITIAL RESULT 111.8 MMOL/L, REPEATED 16.9 MMOL/L; INITIAL RESULT 81.7 MMOL/L, REPEATED 6.9 MMOL/L; INITIAL RESULT 68 MMOL/L, REPEATED 10.1 MMOL/L; INITIAL RESULT 37 MMOL/L, REPEATED 4 MMOL/L.. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1676249 ALINITY C PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 03R6701 00380740137380

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ALIN C TBILI 3600T CN, 04V51-77,| ALIN C TBILI 3600T CN, 04V51-77,