BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CMV IGG REAGENT KIT

    MDR report key: 19800919 · Received July 22, 2024

    Report

    Report Number
    3008344661-2024-00083
    Event Type
    Malfunction
    Date Received
    July 22, 2024
    Date of Event
    July 3, 2024
    Report Date
    September 13, 2024
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LFZ
    UDI-DI
    00380740211172
    PMA / PMN Number
    K220949
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION PROVIDED IN B5. THE INCIDENT INVOLVED ONE PATIENT NOT TWO AS PREVIOUSLY REPORTED. THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND RETAINED PRODUCT ANALYSIS. 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. TICKET SEARCH BY LOT INDICATES THE REAGENT LOT PERFORMS AS EXPECTED. TICKET TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT. A RETAINED REAGENT KIT OF THE COMPLAINT LOT WAS TESTED IN A SPECIFICITY SETUP. ALL SPECIFICATIONS WERE MET AND NO FALSE REACTIVE RESULTS WERE OBTAINED, INDICATING THE SPECIFICITY PERFORMANCE IS NOT IMPACTED. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ARCHITECT CMV IGG REAGENT LOT NUMBER 58634FN00 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.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE REACTIVE ARCHITECT CMV IGG RESULTS ON MULTIPLE PATIENTS. THE RESULTS PROVIDED WERE: PATIENT 1: INITIAL=12.6 AU/ML (>OR=6.0 AU/ML=REACTIVE)/PREVIOUS HISTORY IN (B)(6) 2023=NEGATIVE (NO ACTUAL RESULTS PROVIDED); CMV IGM=NEGATIVE. PATIENT 2: INITIAL=11.5 AU/ML /PREVIOUS HISTORY IN (B)(6) 2023=NEGATIVE (NO ACTUAL RESULTS PROVIDED); CMV IGM=NEGATIVE THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. UPDATE: UPON FURTHER REVIEW, THE INCIDENT ONLY INVOLVED ONE PATIENT FOR FALSE REACTIVE ARCHITECT CMV IGG RESULTS: INITIAL=11.5 AU/ML /PREVIOUS HISTORY IN (B)(6) 2023=NEGATIVE (NO ACTUAL RESULTS PROVIDED); CMV IGM=NEGATIVE. PATIENT 1 INFORMATION WAS INADVERTENTLY PROVIDED BY THE CUSTOMER. IT WAS CONFIRMED WITH THE CUSTOMER THE INFORMATION IS NOT APPLICABLE AND ADDED IN ERROR.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE REACTIVE ARCHITECT CMV IGG RESULTS ON MULTIPLE PATIENTS. THE RESULTS PROVIDED WERE: PATIENT 1: INITIAL=(B)(6) AU/ML (>OR=6.0 AU/ML=REACTIVE)/PREVIOUS HISTORY IN (B)(6) 2023=NEGATIVE (NO ACTUAL RESULTS PROVIDED); CMV IGM=NEGATIVE PATIENT 2: INITIAL=(B)(6) AU/ML /PREVIOUS HISTORY IN (B)(6) 2023=NEGATIVE (NO ACTUAL RESULTS PROVIDED); CMV IGM=NEGATIVE THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2483611 ARCHITECT CMV IGG REAGENT KIT ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS LFZ ABBOTT IRELAND DIAGNOSTICS DIVISION 58634FN00 00380740211172

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARC I2K PROC MOD, 03M74-01, (B)(6)| ARC I2K PROC MOD, 03M74-01, (B)(6)