BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHE DIAGNOSTICS ELECSYS E170 MODULAR ANALYTICS IMMUNOASSAY ANALYZER

    MDR report key: 7210100 · Received January 22, 2018

    Report

    Report Number
    1823260-2018-00190
    Event Type
    Malfunction
    Date Received
    January 22, 2018
    Date of Event
    January 7, 2018
    Report Date
    April 18, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    PRECISION STUDIES WERE PERFORMED. THE FIELD SERVICE ENGINEER CHECKED PROBE ALIGNMENT, CLEANED THE PROBES, AND CHECKED THE GEAR PUMP AND PROBE WASHING. HE CHECKED THE MIXER. HE RAN PERFORMANCE TESTING AND THIS WAS WITHIN RANGE.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR THE ELECSYS TESTOSTERONE II ASSAY (TESTO) ON A ROCHE DIAGNOSTICS ELECSYS E170 MODULAR ANALYTICS IMMUNOASSAY ANALYZER (E170). THE ERRONEOUS RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED AS 15.27 NG/DL. THE SAMPLE WAS REPEATED ON A DIFFERENT ANALYZER, RESULTING AS 487.0 NG/DL. BY MISTAKE, THREE SAMPLE TUBES WERE COLLECTED FROM THE PATIENT, REGISTERED, AND TESTED. ONLY THE COMPLAINED SAMPLE HAD A LOW TESTO RESULT. THE CUSTOMER DID NOT PROVIDE THE RESULTS MEASURED FROM THE OTHER TUBES, BUT SAID THE VALUES WERE AROUND 400 NG/DL. BASED ON THIS, THE REPEAT RESULT OF THE COMPLAINED SAMPLE WAS CONSIDERED TO BE CORRECT. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE TESTO REAGENT LOT NUMBER WAS 232994. THE REAGENT EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED. QUALITY CONTROL RESULTS FROM THE DATE OF THE EVENT WERE WITHIN SPECIFIED RANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54493 ROCHE DIAGNOSTICS ELECSYS E170 MODULAR ANALYTICS IMMUNOASSAY ANALYZER IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E MODULE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR