BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IGM ANTIBODIES TO CYTOMEGALOVIRUS (CMV IGM)

    MDR report key: 5996523 · Received October 4, 2016

    Report

    Report Number
    1823260-2016-01509
    Event Type
    Malfunction
    Date Received
    October 4, 2016
    Date of Event
    September 7, 2016
    Report Date
    October 11, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFZ
    PMA / PMN Number
    K142133
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT SAMPLE WAS SUBMITTED FOR INVESTIGATION. THE SAMPLE WAS TESTED WITH THE ELECSYS CMV IGM IMMUNOASSAY, THE ELECSYS CMV IGG IMMUNOASSAY AND THE ELECSYS CMV IGG AVIDITY TEST ON A COBAS E601 ANALYZER USED AT THE INVESTIGATION SITE. THE SAMPLE WAS ALSO TESTED WITH THE CMV RECOMLINE ASSAY FROM (B)(4). THE SAMPLE WAS NEGATIVE WHEN TESTED WITH THE ELECSYS CMV IGM ASSAY AND POSITIVE WHEN TESTED WITH THE ELECSYS CMV IGG ASSAY. THE ELECSYS CMV IGG AVIDITY TEST DETECTED CMV SPECIFIC IGG ANTIBODIES WITH HIGH AVIDITY. THE CMV SPECIFIC IGG ANTIBODIES WERE OF HIGH AVIDITY AS SHOWN BY THE INVESTIGATION RESULTS AND THE VIDAS RESULTS PROVIDED BY THE CUSTOMER. THE CUSTOMER'S RESULTS COULD BE CONFIRMED. THE NEGATIVE ROCHE CMV IGM RESULTS WERE COMPARABLE TO A RECOMLINE BLOT RESULT THAT WAS NEGATIVE. THE ELECSYS CMV IGM RESULT IS ASSUMED TO BE CORRECTLY NEGATIVE. THE RESULTS FROM THE INVESTIGATION POINT TO A LATE PHASE CMV INFECTION. A HIGH AVIDITY DURING THE FIRST 12-16 WEEKS OF PREGNANCY CAN BE CONSIDERED A GOOD INDICATOR OF A PAST INFECTION. THE DETECTION OF IGM ANTIBODIES CAN SHOW CONSIDERABLE VARIABILITY DEPENDING ON THE ASSAY USED AND THE INDIVIDUAL PATIENT. CERTAIN ASSAYS DETECT PERSISTING IGMS MORE FREQUENTLY THAN OTHERS. THE ADDITIONAL ASSESSMENT OF THE ASSOCIATED IGG AND IGG AVIDITY STATUS IS RECOMMENDED FOR DETERMINING THE STAGE OF INFECTION. ALSO, GUIDELINES PROVIDED BY HEALTHCARE PROVIDERS CAN FURTHER ADVISE ON HOW TO FOLLOW UP ON EVIDENCE OF A CMV INFECTION, ESPECIALLY IN THE CASE WHERE A PRIMARY INFECTION SHOULD OCCUR DURING PREGNANCY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF (B)(6) RESULTS FOR 1 PATIENT TESTED FOR (B)(6). THE (B)(6) RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL PATIENT SAMPLE WAS DRAWN ON (B)(6) 2016 AND THE RESULT ON (B)(6) 2016 FROM THE E602 INSTRUMENT WAS (B)(6) ((B)(6)). AN ADDITIONAL SAMPLE WAS DRAWN ON (B)(6) 2016 AND THE RESULT ON (B)(6) 2016 WAS (B)(6) ((B)(6)) ON THE E602 INSTRUMENT. A REPEAT RESULT BY THE VIDAS METHOD ON (B)(6) 2016 WAS (B)(6) ((B)(6)). A DIFFERENT SAMPLE WAS ALSO TESTED ON (B)(6) 2016 BY THE VIDAS METHOD AND THE RESULT WAS (B)(6) ((B)(6)). IT IS NOT CLEAR WHICH VIDAS RESULT WAS FROM THE (B)(6) 2016 SAMPLE AND WHICH RESULT WAS FROM THE (B)(6) 2016 SAMPLE. THIS INFORMATION WAS REQUESTED BUT NOT PROVIDED. THE RESULTS FROM AN ADDITIONAL METHOD WERE ALSO (B)(6). THE ACTUAL RESULTS WERE NOT PROVIDED. THE PATIENT'S CLINICIAN RECOMMENDED THAT SHE DISCONTINUE HER (B)(6) WEEKS. IT IS NOT KNOWN WHY THIS DECISION WAS MADE. THIS INFORMATION HAS BEEN REQUESTED, BUT COULD NOT BE PROVIDED. THERE IS NO REPORT THAT THIS DECISION WAS MADE BASED ON THE (B)(6) RESULTS FROM THE ROCHE PRODUCT. THE E602 ANALYZER SERIAL NUMBER WAS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647375 IGM ANTIBODIES TO CYTOMEGALOVIRUS (CMV IGM) ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS LFZ ROCHE DIAGNOSTICS NA 190233

    Patients

    Seq Age Sex Outcome Treatment
    1