BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E 601 MODULE

    MDR report key: 7052247 · Received November 22, 2017

    Report

    Report Number
    1823260-2017-02728
    Event Type
    Malfunction
    Date Received
    November 22, 2017
    Date of Event
    October 31, 2017
    Report Date
    December 8, 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

    (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION NOTED THAT THE RESULTS IN IU/L THE CUSTOMER HAS COMPLAINED ABOUT ARE NOT PLAUSIBLE BASED ON THE MEASURING RANGE FOR THE HCG + B ASSAY. THE MEASURING RANGE FOR HCG + B STARTS AT 0.1 IU/L.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF A HIGH ERRONEOUS RESULT FOR 1 PATIENT TESTED FOR ELECSYS HCG + BETA TEST SYSTEM (HCG + B) ON A COBAS 6000 E 601 MODULE. IT IS NOT CLEAR IF THE HIGH RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL HCG + B RESULT WAS 2681 IU/L. THE HIGH RESULT DID NOT CORRESPOND TO THE PATIENT¿S CLINICAL CONDITION. ON (B)(6) 2017 A NEW SAMPLE WAS OBTAINED AND THE RESULT WAS 0.06 IU/L. THIS SAMPLE WAS REPEATED AND THE RESULT WAS 0.05 IU/L. ON (B)(6) 2017 A NEW SAMPLE WAS OBTAINED AND THE RESULT WAS 0.05 IU/L. THIS SAMPLE WAS REPEATED AND THE RESULT WAS 0.05 IU/L. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE HCG + B REAGENT LOT NUMBER WAS 210151. THE EXPIRATION DATE WAS NOT PROVIDED. THE CUSTOMER STATED QUALITY CONTROL (QC) DATA AROUND THE TIME OF THESE TESTS WAS ACCEPTABLE. A SPECIFIC ROOT CAUSE WAS NOT IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED FOR INVESTIGATION BUT WAS NOT PROVIDED. THE CUSTOMER STATED THE ISSUE HAS BEEN RESOLVED AND DECLINED TO PROVIDE ANY ADDITIONAL INFORMATION. POSSIBLE ROOT CAUSES FOR THIS EVENT MAY BE INSUFFICIENT ELECTROMAGNETIC INTERFERENCE LAB COMPLIANCE, SAMPLE QUALITY, INSUFFICIENT MAINTENANCE, OR CONTAMINATION OF THE ENVIRONMENT WITH THE ANALYTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832160 COBAS 6000 E 601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1