BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 CORE UNIT

    MDR report key: 6945075 · Received October 12, 2017

    Report

    Report Number
    1823260-2017-02293
    Event Type
    Malfunction
    Date Received
    October 12, 2017
    Date of Event
    August 30, 2017
    Report Date
    December 19, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. THE MOST LIKELY CAUSE WAS A PRE-ANALYTICAL ISSUE AS THE SAMPLE HANDLING WAS NOT OPTIMAL. TYPICAL ROOT CAUSES FOR THIS TYPE OF EVENT INCLUDE INSUFFICIENT ELECTROMAGNETIC INTERFERENCE (EMI) COMPLIANCE, ISSUES WITH SAMPLE QUALITY, INSUFFICIENT MAINTENANCE, OR CONTAMINATION OF THE ENVIRONMENT WITH THE ANALYTE. OTHER POSSIBLE CAUSES INCLUDE BUBBLES OR FOAM ON REAGENT SURFACE OR ON SYSTEM REAGENT SURFACE.

    Additional Manufacturer Narrative · 1

    THE REAGENT LOT NUMBERS WERE PROVIDED AS 189279 AND 220841.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE ELECSYS TSH ASSAY AND ELECSYS FT4 ASSAY RESULTS FOR ONE PATIENT SAMPLE. IN EARLY (B)(6), THE TSH RESULT FOR THE PATIENT WAS 4.63. THE PATIENT "HAD OWN SMALL AMOUNTS OF DRUGS TO TREAT HYPOTHYREA" UNTIL (B)(6) 2017. ON (B)(6) 2017, THE TSH RESULT WAS STILL RELATIVELY HIGH AT 4.27, SO THE PATIENT WENT TO ANOTHER HOSPITAL FOR TESTING AND THE TSH RESULT WAS 0.10. THE PATIENT'S FT4 RESULT WAS 13.74. ON (B)(6) 2017, THE CUSTOMER REPEATED THE SAME SAMPLE FROM (B)(6) 2017. THE REPEAT TSH RESULT WAS 0.09 AND THE REPEAT FT4 RESULT WAS 17.02. NO UNITS OF MEASURE WERE PROVIDED. NO ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723376 COBAS 6000 CORE UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS COBAS 6000 CORE NA

    Patients

    Seq Age Sex Outcome Treatment
    1