BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IGG ANTIBODIES TO RUBELLA VIRUS

    MDR report key: 4962618 · Received August 3, 2015

    Report

    Report Number
    1823260-2015-03917
    Event Type
    Malfunction
    Date Received
    August 3, 2015
    Date of Event
    May 13, 2015
    Report Date
    October 13, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFX
    PMA / PMN Number
    K072617
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. FURTHER INVESTIGATION CONFIRMED THE SAMPLES WERE TRULY POSITIVE. IT WAS NOTED BOTH REAGENT LOTS PERFORMED WITHIN THE SPECIFICATIONS FOR QC. DUE TO THE HETEROGENEITY OF THE ANALYTE, LOT-TO-LOT VARIATIONS CANNOT BE COMPLETELY EXCLUDED.

    Additional Manufacturer Narrative · 1

    SAMPLES FROM THE PATIENT WERE SUBMITTED FOR INVESTIGATION. THE CUSTOMER'S NEGATIVE RESULTS WITH REAGENT LOT 182963 AND POSITIVE RESULTS WITH REAGENT LOT 185927 WERE REPRODUCED.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE LOW IGG ANTIBODIES TO RUBELLA VIRUS RESULTS FOR ONE PATIENT FROM COBAS E601 SERIAL NUMBER (B)(4). WITH REAGENT LOT 182963, IT APPEARED THE PATIENT WAS NOT IMMUNIZED, BUT WITH REAGENT LOT 185927 IT APPEARED THE PATIENT WAS IMMUNIZED. THE RESULTS WERE REAGENT LOT 182963 WERE: (B)(6) 2015: 6.0. 06/09/2015: 6.3. THE RESULTS WERE REAGENT LOT 185927 WERE: (B)(6) 2015: 11.47 AND 11.52. (B)(6) 2015: 12.08 AND 12.48. (B)(6) 2015: 12.5 AND 13.1. THE RESULTS FROM (B)(6) 2015 AND (B)(6) 2015 WERE REPORTED TO THE PATIENT AND THE PRESCRIBER. THE PATIENT WAS NOT ADVERSELY AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503687 IGG ANTIBODIES TO RUBELLA VIRUS ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA LFX ROCHE DIAGNOSTICS NA 182963

    Patients

    Seq Age Sex Outcome Treatment
    1 039 YR