BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IGM ANTIBODIES TO CYTOMEGALOVIRUS (CMV IGM)

    MDR report key: 6939554 · Received October 11, 2017

    Report

    Report Number
    1823260-2017-02249
    Event Type
    Malfunction
    Date Received
    October 11, 2017
    Date of Event
    September 19, 2017
    Report Date
    January 11, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFZ
    PMA / PMN Number
    K142133
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE WAS NOT IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED FOR INVESTIGATION BUT WAS NOT PROVIDED. SINCE THE PATIENT SAMPLE WAS NOT AVAILABLE, THE INVESTIGATION COULD NOT BE COMPLETED.

    Additional Manufacturer Narrative · 1

    A SAMPLE FROM THE PATIENT WAS SUBMITTED FOR INVESTIGATION. THE SAMPLE WAS TESTED WITH ELECSYS CMV IGM ON A MODULAR E170 ANALYZER. THE SAMPLE WAS ALSO TESTED WITH ELECSYS CMV IGG ON THE MODULAR E170 ANALYZER AND WITH ELECSYS CMV IGG AVIDITY ON A COBAS E801 MODULE. THE CMV IGM RESULT WAS 0.4 COI (NEGATIVE). THE CMV IGG RESULT WAS 115.6 U/ML (POSITIVE). THE CMV IGG AVIDITY WAS 70.4% (153 U/ML). THE CUSTOMER'S CMV IGM RESULT WAS REPRODUCED. THE CMV IGG RESULT WAS POSITIVE AND THE CMV IGG AVIDITY SHOWED A HIGH VALUE. BASED ON THE INFORMATION AVAILABLE, A GENERAL REAGENT ISSUE CAN BE EXCLUDED. INVESTIGATIONS ARE ONGOING.

    Additional Manufacturer Narrative · 1

    THE E601 MODULE SERIAL NUMBER WAS (B)(4). CALIBRATION AND QC RESULTS WERE WITHIN THE SPECIFIED RANGES. THE PATIENT SAMPLE WAS INVESTIGATED FURTHER BY THE RECOMLINE METHOD: THE CMV IGM RESULT WAS POSITIVE. THE CMV IGG RESULT WAS POSITIVE. THE CUSTOMER'S ALLEGATION COULD BE REPRODUCED. DURING AN EARLIER PHASE IN THE INVESTIGATION THE PATIENT SAMPLE TESTED NEGATIVE FOR CMV IGM BY THE ROCHE ASSAY, HOWEVER THE NEWLY GENERATED DATA STRONGLY SUGGEST THAT THE PATIENT IS ALREADY IN A LATE PHASE OF A CMV INFECTION. THIS INTERPRETATION IS PREDOMINANTLY BASED ON THE PRESENCE OF CMV SPECIFIC IGG ANTIBODIES THAT SHOW HIGH AVIDITY (CMV IGG AVIDITY WAS 70.4%). THE RESULTS FROM THE REMOMLINE METHOD ALSO SUPPORT THIS INTERPRETATION.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER WAS RUNNING A VALIDATION STUDY ON A NEWLY INSTALLED COBAS 6000 E 601 MODULE WITH THE ELECSYS CMV IGM IMMUNOASSAY (CMV IGM). THE CUSTOMER WAS COMPARING PATIENT SAMPLES THAT HAD TESTED POSITIVE BY THE ABBOTT METHOD AND RUNNING THEM ON THE E601 MODULE. DURING THIS PROCESS, THE CUSTOMER IDENTIFIED A FALSE NEGATIVE RESULT FOR 1 PATIENT SAMPLE THAT WAS REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL CMV IGM RESULT FROM THE ABBOTT METHOD WAS 2.53 COI (POSITIVE). THE SAME SAMPLE WAS REPEATED ON THE E601 MODULE AND THE RESULT WAS 0.441 COI (NEGATIVE). ON (B)(6) 2017 THE SAMPLE WAS SENT TO AN EXTERNAL LABORATORY USING THE VIDAS METHOD AND THE RESULT WAS 1.23 COI (POSITIVE) WITH THE RECOMMENDATION THAT AN AVIDITY TEST BE PERFORMED. THE CUSTOMER REPORTED THE NEGATIVE CMV IGM RESULT OF 0.441 COI FROM THE E601 MODULE BY MISTAKE WITHOUT WAITING FOR THE CONFIRMATORY TEST. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE E601 MODULE SERIAL NUMBER WAS NOT PROVIDED. THE PATIENT SAMPLE IS NO LONGER AVAILABLE FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720888 IGM ANTIBODIES TO CYTOMEGALOVIRUS (CMV IGM) ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS LFZ ROCHE DIAGNOSTICS NA 21691601

    Patients

    Seq Age Sex Outcome Treatment
    1