BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E 601 MODULE

    MDR report key: 7161446 · Received January 3, 2018

    Report

    Report Number
    1823260-2018-00040
    Event Type
    Malfunction
    Date Received
    January 3, 2018
    Date of Event
    December 14, 2017
    Report Date
    January 29, 2018
    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)(4). THIS EVENT OCCURRED IN (B)(6). (B)(6).

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. POSSIBLE ROOT CAUSES INCLUDE REAGENT ISSUES AS NO VALID QC WAS MEASURED, INSTRUMENT PERFORMANCE ISSUES AS ANALYZER PERFORMANCE DATA SHOWED VALUES OUT OF SPECIFICATIONS, AND PRE-ANALYTICS ISSUES. THE PROVIDED LAB HUMIDITY MEASUREMENT WAS FOUND TO BE OUT OF SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE LOW ELECSYS HCG + BETA TEST SYSTEM RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 3953 MIU/ML AND THE REPEAT RESULTS WERE >10000 AND 87801 MIU/ML. NO ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE REAGENT LOT NUMBER WAS 210151. THE EXPIRATION DATE WAS REQUESTED BUT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6232 COBAS 6000 E 601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1