BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C (501) MODULE

    MDR report key: 5956371 · Received September 16, 2016

    Report

    Report Number
    1823260-2016-01393
    Event Type
    Malfunction
    Date Received
    September 16, 2016
    Date of Event
    August 27, 2016
    Report Date
    October 11, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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. QUALITY CONTROLS WERE ACCEPTABLE. BASED ON A REVIEW OF THE ALARM TRACE, "ABNORMAL PROBE SUCKING" ALARMS WERE PRODUCED ON 08/25/2016 AND 08/27/2016. THE INVESTIGATION STATES THAT THE MOST LIKELY ROOT CAUSE OF THE ISSUE WAS A SAMPLE PIPETTING ISSUE DUE TO BUBBLES ON SAMPLES AND INCORRECT POSITIONING OF THE TUBES IN THE RACK.

    Description of Event or Problem · 1

    THE CUSTOMER QUESTIONED RESULTS FOR 16 PATIENT SAMPLES TESTED FOR D-DI TINA-QUANT D-DIMER (D-DI). OF THE DATA PROVIDED, 7 PATIENT SAMPLES WERE ERRONEOUS AND REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULTS WERE CONSIDERED TO BE CORRECT. AFTER THE SAMPLES WERE REPEATED, CORRECTED REPORTS WERE SENT. REFER TO THE ATTACHED DATA FOR PATIENT RESULTS. NO ADVERSE EVENT OCCURRED. THE D-DI REAGENT LOT NUMBER WAS 131379. THE EXPIRATION DATE WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE (FSR) IDENTIFIED BUBBLES ON SOME OF THE SAMPLES. THE CUSTOMER WAS ADVISED TO CHECK THIS BEFORE LOADING THE SAMPLES ONTO THE INSTRUMENT. IT WAS NOTED THAT THE CUSTOMER SOMETIMES LIFTS THE TUBE IN THE RACK DUE TO BAR CODE READING ISSUES. THE FSR ADVISED THE CUSTOMER AGAINST THIS AS IT COULD CAUSE POSSIBLE PIPETTING ISSUES. IT WAS ALSO NOTED THAT MANY OF THE SAMPLES CAME FROM EXTERNAL LABORATORIES IN A SECONDARY TUBE ALREADY FROZEN. THE SAMPLES WERE THAWED AT ROOM TEMPERATURE AND MANUALLY HOMOGENIZED. BETWEEN THE INITIAL AND REPEAT RESULTS THE SAMPLES WERE REFRIGERATED. BEFORE THE SAMPLES WERE REPEATED, THE SAMPLES WERE CENTRIFUGED. THE CUSTOMER WAS ADVISED TO FOLLOW THE INSTRUCTIONS IN PRODUCT LABELING MAKING SURE TO CENTRIFUGE THE SAMPLES PRIOR TO ANALYSIS IF PARTICLES ARE OBSERVED. THE LAST MONTHLY MAINTENANCE WAS ON 08/28/2016 WITH CUVETTE AND LAMP EXCHANGE. A POSSIBLE ROOT CAUSE MAY BE SAMPLE PIPETTING ISSUES RELATED TO BUBBLES ON THE SAMPLE AND ALSO INCORRECT POSITIONING OF TUBES IN THE RACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608615 COBAS 6000 C (501) MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C501 NA

    Patients

    Seq Age Sex Outcome Treatment
    1