BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C701 MODULE

    MDR report key: 3172569 · Received June 17, 2013

    Report

    Report Number
    1823260-2013-03613
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 15, 2013
    Report Date
    September 27, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Additional Manufacturer Narrative · 1

    DUE TO THE LACK OF DATA AND INFORMATION FROM THE CUSTOMER, A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. SINCE MULTIPLE MODULES OF THE ANALYZER WERE INVOLVED, A SAMPLE SPECIFIC ISSUE WAS THE MOST LIKELY CAUSE.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FOR MULTIPLE ASSAYS FOR ONE PATIENT SAMPLE. OF THE DATA PROVIDED, ONLY THE RESULTS FOR CALCIUM, GLUCOSE, TOTAL PROTEIN AND ASPARTATE AMINOTRANSFERASE (AST) WERE DISCREPANT AND REPORTED OUTSIDE THE LABORATORY. THE INITIAL CALCIUM RESULT WAS 6.6 MG/DL AND THE REPEAT RESULT WAS 9.9 MG/DL. THE INITIAL GLUCOSE RESULT WAS 58 MG/DL AND THE REPEAT RESULT WAS 82 MG/DL. THE INITIAL TOTAL PROTEIN RESULT WAS 4.9 G/DL AND THE REPEAT RESULT WAS 7.1 G/DL. THE INITIAL AST RESULT WAS 14 U/L AND REPEAT RESULT WAS 22 U/L. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE CALCIUM REAGENT LOT NUMBER WAS 67213601 WITH AN EXPIRATION DATE OF 11/30/2013. THE GLUCOSE REAGENT LOT NUMBER WAS 66901201 WITH AN EXPIRATION DATE OF 11/30/2013. THE TOTAL PROTEIN REAGENT LOT NUMBER WAS 67424801 WITH AN EXPIRATION DATE OF 03/31/2014. THE AST REAGENT LOT NUMBER WAS 67113901 WITH AN EXPIRATION DATE OF 01/31/2014. THE CUSTOMER DECLINED A SERVICE VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273861 COBAS 8000 C701 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1