BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 2875092 · Received December 17, 2012

    Report

    Report Number
    1823260-2012-06341
    Event Type
    Malfunction
    Date Received
    December 17, 2012
    Date of Event
    October 9, 2012
    Report Date
    February 7, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LGD
    PMA / PMN Number
    K060373
    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

    THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE. A SAMPLE FROM THE PATIENT WAS SUBMITTED FOR TESTING AND THE CUSTOMER'S NEGATIVE RESULTS WERE CONFIRMED. EVALUATION OF THE PROVIDED CALIBRATION AND QC DATA SHOWED RESULTS WITHIN THE EXPECTED RANGES.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE FALSE NEGATIVE TOXOPLASMA IGG (IGG ANTIBODIES TO TOXOPLASMA GONDII) RESULTS FOR TWO SAMPLES FROM ONE PATIENT. THE RESULT FROM THE FIRST SAMPLE WAS <0.130. THE RESULTS FROM ANOTHER LABORATORY ON (B)(6) 2012 WERE: TOXOPLASMA IGG (AG) : NEG TOXOPLASMA IGG IE : 14.9 UI/ML (ELISA PLATELIA TOXOPLASMA IGG BIORAD) IGG IF (IMMUNOFLUORESCENCE): 10 UI/ML LOBIO TOXOPLASMA II IGG (LOBIO DIAGNOSTICS) INTERPRETATION: POSITIVE FOR THE SECOND SAMPLE FROM (B)(6) 2012, THE RESULT WAS <0.130 THE RESULTS FROM ANOTHER LABORATORY ON (B)(6) 2012 WERE: TOXOPLASMA IGG (AG) : NEG TOXOPLASMA IGG IE : 14.9 UI/ML (ELISA PLATELIA TOXOPLASMA IGG BIORAD) IGG IF (IMMUNOFLUORESCENCE) : 10 UI/ML LOBIO TOXOPLASMA II IGG (LOBIO DIAGNOSTICS) INTERPRETATION: POSITIVE THE PATIENT WAS NOT ADVERSELY AFFECTED. THE TOXOPLASMA IGG REAGENT LOT NUMBER WAS 169150. THE EXPIRATION DATE WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER LGD ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 037 YR