BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR

    MDR report key: 14379810 · Received May 12, 2022

    Report

    Report Number
    3016438761-2022-00209
    Event Type
    Malfunction
    Date Received
    May 12, 2022
    Date of Event
    March 24, 2022
    Report Date
    June 24, 2022
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740006235
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE SERVICE HISTORY OF THE (B)(6) VERIFIES NO SUBSEQUENT ISSUES HAVE BEEN REPORTED RELATED TO FALSELY ELEVATED AND OR IMPRECISION CMV IGG RESULT. TRENDING REVIEW DETERMINED NO ADVERSE TREND FOR THE ISSUE FOR THE PRODUCT. DEVICE HISTORY RECORD REVIEW DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES, OR DEVIATIONS. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED DISCREPANT ARCHITECT CMV IGG AVIDITY RESULTS FOR PATIENT SAMPLES USING DIFFERENT DILUTION PROTOCOLS. THE CUSTOMER INQUIRED AS TO WHY SAMPLES WITH CMV IGG VALUES AROUND 150 AU/ML ARE SHOWING DISCREPANCIES IN AVIDITY RESULTS (FALSELY ELEVATED). THE FOLLOWING PATIENT DATA WAS PROVIDED. PATIENT 1: SAMPLE 1: CMV IGG 153.8 AU/ML, CMV IGM 3.07 INDEX, CMV IGG AVIDITY (50-150 DILUTION) 28.4 %AVI (LOW AVIDITY), CMV IGG AVIDITY (150-500 DILUTION) 67.3 %AVI (HIGH AVIDITY). PATIENT 2: SAMPLE 1: CMV IGG 145.6 AU/ML, CMV IGM 0.92 INDEX, CMV IGG AVIDITY (50-150 DILUTION) 47.8 %AVI (LOW AVIDITY). SAMPLE 2: CMV IGG 157.2 AU/ML, CMV IGM 0.84 INDEX, CMV IGG AVIDITY (50-150 DILUTION) 52.1 %AVI (GRAYZONE), CMV IGG AVIDITY (150-500 DILUTION) 75.4 %AVI (HIGH AVIDITY). IN THIS LAB, THERE WERE ADDITIONAL SAMPLES USING THE DILUTION PROTOCOLS THAT ALSO SHOWED A DISCREPANCY IN AVIDITY RESULTS (LOW VERSUS HIGH). NO %AVI VALUES WERE PROVIDED. SID (B)(6): 24/03/2022 CMV IGG 153.8 AU/ML, CMV IGM 3.07 INDEX, (50-150 DILUTION). SID (B)(6): 24/03/2022 CMV IGG 153.8 AU/ML, CMV IGM 3.07 INDEX, (150-500 DILUTION). SID (B)(6): 25/04/2022 CMV IGG 157.2 AU/ML, CMV IGM 0.84 INDEX, (50-150 DILUTION). SID (B)(6): 25/04/2022 CMV IGG 157.2 AU/ML, CMV IGM 0.84 INDEX, (150-500 DILUTION). SID (B)(6): 06/04/2022 CMV IGG 145.6 AU/ML, CMV IGM 0.92 INDEX, (50-150 DILUTION). INTERPRETATION OF RESULTS: < 50.0 %AVI: LOW AVIDITY, 50.0 ¿ 59.9 %AVI: GRAYZONE, = 60.0 %AVI: HIGH AVIDITY. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381123 ARCHITECT I2000SR ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 3M74-02 00380740006235

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ARC CMV-G AV RGT, 03L46-25, 36001FN00| ARC CMV-G AV RGT, 03L46-25, 36001FN00