BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CMV IGG REAGENT KIT

    MDR report key: 19983188 · Received August 14, 2024

    Report

    Report Number
    3008344661-2024-00093
    Event Type
    Malfunction
    Date Received
    August 14, 2024
    Date of Event
    July 25, 2024
    Report Date
    September 30, 2024
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LFZ
    UDI-DI
    0038074021117
    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

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION HAS BEEN INCLUDED. NO ADDITIONAL PATIENT DETAILS ARE AVAILABLE.

    Additional Manufacturer Narrative · 0

    DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. TICKET SEARCH BY LOT INDICATES NORMAL COMPLAINT ACTIVITY. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER¿S OBSERVATION. A REVIEW OF TICKET TRENDING DID NOT IDENTIFY ANY RELATED TREND REGARDING COMMONALITIES FOR COMPLAINT LOT NUMBER AND ISSUE. CLINICAL SENSITIVITY TESTING MET ACCEPTANCE CRITERIA AND THE PRODUCT IS PERFORMING AS EXPECTED. LABELLING REVIEW CONCLUDES THAT THE ISSUE IS ADEQUATELY ADDRESSED. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT CMV IGG ASSAY WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE NONREACTIVE ARCHITECT CMV IGG RESULTS FOR ONE PREGNANT PATIENT. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2024 IGG NEGATIVE; IGM POSITIVE: 2.95 S/CO. (B)(6) 2024 IGG NEGATIVE, IGM POSITIVE: 2.51 S/CO. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE NONREACTIVE ARCHITECT CMV IGG RESULTS FOR ONE PREGNANT PATIENT. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2024 IGG NEGATIVE; IGM POSITIVE: 2.95 S/CO. (B)(6) 2024 IGG NEGATIVE, IGM POSITIVE: 2.51 S/CO. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262164 ARCHITECT CMV IGG REAGENT KIT ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS LFZ ABBOTT IRELAND DIAGNOSTICS DIVISION 61380FZ00 0038074021117

    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)