BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS CMV IGG ASSAY

    MDR report key: 11672502 · Received April 15, 2021

    Report

    Report Number
    1823260-2021-01149
    Event Type
    Malfunction
    Date Received
    April 15, 2021
    Date of Event
    March 23, 2021
    Report Date
    June 10, 2021
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFZ
    PMA / PMN Number
    K131605
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S CALIBRATION AND QC DATA WERE REQUESTED BUT NOT PROVIDED. THE INVESTIGATION PERFORMED FURTHER TESTING WITH THE PATIENT'S SAMPLE. THE PATIENT'S RECOMLINE CMV IGG WAS NEGATIVE. THE PATIENT'S CMV IGG SUBMODULE ASSAY RESULT WAS DOMINANT REACTIVITY TO MODULE 4. THE INVESTIGATION DETERMINED THE SAMPLE CAUSED A FALSE REACTIVE RESULT WITH THE ELECSYS CMV IGG ASSAY DUE TO AN UNSPECIFIED INTERFERENT. THE PATIENT SHOULD BE CONSIDERED SERONEGATIVE FOR CMV. BASED ON THE SPECIFICITY OF THE ELECSYS CMV IGG ASSAY, FALSE POSITIVES CAN OCCUR. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION TESTED THE PATIENT'S SAMPLE AND RECEIVED THE FOLLOWING RESULTS: CMV IGM: 0.143 COI NON-REACTIVE CMV IGG: 1.35 U/ML REACTIVE CMV IGG AVIDITY: 84.3 % THE INVESTIGATION CONFIRMED THE CUSTOMER'S RESULTS. BASED ON THE AVAILABLE INFORMATION, A GENERAL REAGENT ISSUE COULD BE EXCLUDED. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). THE PATIENT'S SAMPLE WAS PROVIDED FOR AN INVESTIGATION. THE INVESTIGATION IS ONGOING. UNIQUE DEVICE IDENTIFIER (UDI): (B)(4).

    Description of Event or Problem · 1

    THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS CMV IGG ASSAY RESULTS FOR ONE PATIENT TESTED ON A COBAS 8000 E 801 MODULE SERIAL NUMBER (B)(4). THE PATIENT'S INITIAL ELECSYS CMV IGG RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT'S PHYSICIAN QUESTIONED THE ELECSYS CMV IGG RESULT DUE TO THE RESULT NOT MATCHING THE PATIENT'S CLINICAL STATUS. THE CUSTOMER REPEATED THE SAMPLE ON A MIKROGEN RECOM LINE WESTER BLOT ANALYZER. ALSO, THE PATIENT'S SAMPLE WAS SENT TO A DIFFERENT LABORATORY AND WAS TESTED ON AN E 801 MODULE. ON (B)(6) 2021, THE PATIENT'S INITIAL ELECSYS CMV IGG RESULT WAS 1.32 U/ML REACTIVE. THE PATIENT'S REPEAT CMV IGG RESULT ON THE MIKROGEN RECOM LINE WESTER BLOT ANALYZER WAS NON-REACTIVE. THE DATE OF MEASUREMENT WAS REQUESTED BUT NOT PROVIDED. ON (B)(6) 2021, THE PATIENT'S SECOND REPEAT CMV IGG RESULT ON A DIFFERENT E 801 MODULE WAS 1.24 U/ML REACTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571898 ELECSYS CMV IGG ASSAY ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS LFZ ROCHE DIAGNOSTICS NA 52258300

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR