BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C (501) MODULE

    MDR report key: 6233847 · Received January 9, 2017

    Report

    Report Number
    1823260-2017-00051
    Event Type
    Malfunction
    Date Received
    January 9, 2017
    Date of Event
    November 30, 2016
    Report Date
    January 31, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. ADDITIONAL INFORMATION REQUIRED FOR THE INVESTIGATION WAS REQUESTED, BUT NOT PROVIDED. THE CALIBRATION TRACE FROM THE DAY OF THE EVENT DID NOT INDICATE AN ISSUE. IT IS ASSUMED THAT A HARDWARE ISSUE, SUCH AS THE MISALIGNED SAMPLE PROBE, WAS THE REASON FOR THE ERRONEOUSLY LOW RESULT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR FERR4 TINA-QUANT FERRITIN GEN.4 (FERR) ON A COBAS 6000 C (501) MODULE - C501. IT WAS ASKED, BUT IT IS NOT KNOWN IF AN ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED AS 6 NG/ML. THE PATIENT HAD A PREVIOUS FERR RESULT OF 141 NG/ML ON (B)(6) 2016. A NEW SAMPLE WAS THEN TESTED ON (B)(6) 2016, RESULTING AS 103 NG/ML. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE FERR REAGENT LOT NUMBER WAS 152094. THE REAGENT EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED. THE SAMPLE PROBE WAS ADJUSTED AND PRECISION STUDIES WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15717 COBAS 6000 C (501) MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C501 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR