BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C (501) MODULE

    MDR report key: 7156672 · Received January 2, 2018

    Report

    Report Number
    1823260-2018-00015
    Event Type
    Malfunction
    Date Received
    January 2, 2018
    Date of Event
    December 18, 2017
    Report Date
    January 23, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    NO SIMILAR EVENTS HAVE OCCURRED AT THE CUSTOMER SITE WITHIN THE PAST 12 MONTHS. NO ABNORMAL COMPLAINT TRENDS WERE IDENTIFIED FOR THE TUBING REPLACED BY THE FIELD SERVICE ENGINEER.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED QUESTIONABLE RESULTS FOR TWO SAMPLES TESTED FOR AST ASPARTATE AMINOTRANSFERASE AND CA2 CALCIUM GEN.2 (CA) ON THE COBAS 6000 C (501) MODULE - C501. OF THE TWO SAMPLES, ONE HAD AN ERRONEOUS CA RESULT. THE ERRONEOUS RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED AS 6.41 MG/DL AND REPEATED AS 8.51 MG/DL. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE CUSTOMER STATED THAT THE ANALYZER MADE A NOISE AT THE TIME OF OCCURRENCE AND A RINSE UNIT ALARM WAS ISSUED BY THE ANALYZER. THE FIELD SERVICE ENGINEER DETERMINED THAT A DETERGENT NOZZLE WAS LEAKING AFTER DISPENSE. HE TRIED TO CLEAN THE NOZZLE, BUT THERE WAS NO EFFECT. HE REPLACED A VALVE BANK, BUT THERE WAS NO CHANGE. HE CHECKED FURTHER AND FOUND THAT THERE WAS AN ISSUE WITH TUBING. HE REPLACED THE TUBING. HE PERFORMED MECHANISM CHECKS AND THESE WERE OK. HE RAN PRECISION STUDIES AND THESE WERE OK. THE CUSTOMER RAN CALIBRATIONS AND QUALITY CONTROLS; THESE WERE OK. HE FOLLOWED UP WITH THE CUSTOMER AND THE CUSTOMER STATED THAT THE INSTRUMENT WAS RUNNING OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1083 COBAS 6000 C (501) MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C501 NA

    Patients

    Seq Age Sex Outcome Treatment
    1