BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E 601 MODULE

    MDR report key: 6184858 · Received December 19, 2016

    Report

    Report Number
    1823260-2016-01983
    Event Type
    Malfunction
    Date Received
    December 19, 2016
    Date of Event
    November 29, 2016
    Report Date
    January 13, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. THIS TYPE OF SCENARIO USUALLY INDICATES AN ISSUE WITH THE BEAD CAPTURING. THE TYPICAL CAUSE FOR THIS IS CONTAMINATION OF THE LIQUID FLOW PATH OR MEASURING CELL DUE TO A PREANALYTIC ISSUE WITH THE SAMPLE, SUCH AS INSOLUBLE MATERIAL, ANTI-COAGULATION TREATMENT, OR HIGH PROTEIN CONTAINING SAMPLES. THE ANALYZER WAS CHECKED AND FOUND WORKING WITHIN SPECIFICATION AND PERFORMANCE TESTING WAS DONE AND WAS ACCEPTABLE. NO FURTHER ISSUES WERE REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER EXPERIENCED AN ISSUE WITH QUESTIONABLE RESULTS FOR MULTIPLE ASSAYS ON (B)(6) 2016. ON (B)(6) 2016, THE LABORATORY WAS REQUESTED TO REPEAT ELECSYS FT4 II ASSAY TESTING FOR SOME SAMPLES WITH HIGH RESULTS. AFTER INVESTIGATION, IT WAS FOUND ALL SAMPLES TESTED ON ONE MEASURING CELL OF THE ANALYZER WERE AFFECTED. THE TOTAL NUMBER OF PATIENT SAMPLES INVOLVED WAS UNKNOWN. OF THE DATA PROVIDED, 172 DISCREPANT RESULTS WERE RECEIVED FOR THE ELECSYS FOLATE III ASSAY, 18 DISCREPANT RESULTS WERE RECEIVED FOR THE ELECSYS FT4 II ASSAY, 11 DISCREPANT RESULTS WERE RECEIVED FOR TROPONIN T HS, AND 11 DISCREPANT RESULTS WERE RECEIVED FOR THE ELECSYS PROLACTIN ASSAY. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. NO UNITS OF MEASURE WERE PROVIDED. ALL OF THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE REAGENT LOT NUMBERS WERE FOLATE 144782, FT4 180429, TROPONIN T HS 138696, AND PROLACTIN 143577. THE EXPIRATION DATES WERE REQUESTED BUT WERE NOT PROVIDED. ROUTINE MAINTENANCE WAS PERFORMED ON (B)(6) 2016 AND QC PERFORMED ON THE ANALYZER ON (B)(6) 2016 WAS ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837690 COBAS 6000 E 601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1