BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 3240863 · Received July 22, 2013

    Report

    Report Number
    1823260-2013-04405
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 26, 2013
    Report Date
    August 29, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNITS OF MEASURE USED FOR FPSA ARE UG/L.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE DATE OF THE EVENT WAS (B)(6) 2013. PATIENTS 23, 28, AND 29 WERE SENT TO THE ER BY THE GENERAL PHYSICIAN BASED ON INITIAL RESULT. PATIENT 29 WAS ADMITTED AND HOSPITALIZED IN THE CCU FOR ONE NIGHT BASED ON THE ELEVATED TNT RESULT. AFTER THE CUSTOMER BECAME AWARE OF THE FALSE RESULTS, PATIENTS 23 AND 28 WERE SENT HOME WITHIN 2 HOURS. ALL OF THESE PATIENTS WERE NOT ADVERSELY AFFECTED. THE UNITS OF MEASURE FOR SOME OF THE ASSAYS ARE AS FOLLOWS: TNT = NG/L, TSH = MU/L, FT4 = PMOL/L, TPSA = UG/L, ANTI TPO = U/ML, CORT = UMOL/L, CKMB = UG/L, PTH = PMOL/L. THE FIELD SERVICE REPRESENTATIVE CHECKED THE SYSTEM AND FOUND A LEAKAGE OF A SIPPER TUBE. HE REPLACED THE SIPPER TUBE 2 ASSEMBLY AND SIPPER NOZZLE 2. HE REPLACED THE PINCH VALVE TUBINGS AND THE "2X TUBE JOINT B2". HE CLEANED AND CHECKED THE SIPPER 2 ASSEMBLY.

    Additional Manufacturer Narrative · 1

    PATIENT 1 HAD A TSH RESULT OF 3.37 MU/I. FOR PATIENT 8, THE M1 CKMB RESULT OF 0.1 UG/L WAS ACCOMPANIED BY A DATA FLAG. THIS PATIENT HAD AN ADDITIONAL CKMB VALUE OF 7.02 PMOL/L. IT IS NOT KNOWN IF THIS IS A THIRD VALUE FROM THE PATIENT OR IF THIS CORRESPONDS TO THE ORIGINAL M2 VALUE OF 7.02 PMOL/L. A REQUEST FOR CLARIFICATION OF THIS INFORMATION HAS BEEN SENT. PATIENT 11 HAD A TSH RESULT OF 2.37 MU/I. PATIENT 13 HAD A TSH RESULT OF 2.80 MU/I. PATIENT 15 HAD TSH VALUES OF 0.277 MU/I AND 0.298 MU/I. IT IS NOT CLEAR IF THESE ARE M1 OR M2 VALUES OR IF THE 0.298 MU/I VALUE IS CORRECT. A REQUEST FOR CLARIFICATION OF THIS INFORMATION HAS BEEN SENT. PATIENT 17 HAD A CORTISOL VALUE OF 0.02, BUT IT IS NOT KNOWN IF THIS VALUE ACTUALLY IS A CORTISOL VALUE, IF IT IS AN M1 OR M2 VALUE, IF IT REPRESENTS A THIRD CORTISOL VALUE, OR IF THIS VALUE IS CONVERTED AND CORRESPONDS TO THE M2 VALUE OF 20 UMOL/L ORIGINALLY PROVIDED. A REQUEST FOR CLARIFICATION OF THIS INFORMATION HAS BEEN SENT. THIS PATIENT ALSO HAD A CORTISOL VALUE OF 24.75 UMOL/L, BUT IT IS NOT KNOWN IF THIS VALUE REPRESENTS A FOURTH CORTISOL VALUE OR IF IT CORRESPONDS TO A CORTISOL VALUE THAT WAS ALREADY PROVIDED. A REQUEST FOR CLARIFICATION OF THIS INFORMATION HAS BEEN SENT. THIS PATIENT HAD A T3 VALUE OF 1.83. THE UNITS OF MEASURE FOR THE T3 ASSAY ARE UNKNOWN. PATIENT 18 HAD A TSH RESULT OF 0.005 MU/I ACCOMPANIED BY A DATA FLAG. PATIENT 19 HAD A TSH RESULT OF 2.75 MU/I. PATIENT 21 HAD A TSH RESULT OF 2.79 MU/I. PATIENT 23 HAD A TSH RESULT OF 2.97 MU/I. FOR PATIENT 25, THE M1 CORTISOL RESULT OF 1750 UMOL/L WAS ACCOMPANIED BY A DATA FLAG. THIS PATIENT HAD A CORTISOL VALUE OF 0.91, BUT IT IS NOT KNOWN IF THIS VALUE ACTUALLY IS A CORTISOL VALUE, IF IT IS AN M1 OR M2 VALUE, IF IT REPRESENTS A THIRD CORTISOL VALUE, OR IF THIS VALUE IS CONVERTED AND CORRESPONDS TO THE M2 VALUE OF 910 UMOL/L ORIGINALLY PROVIDED. A REQUEST FOR CLARIFICATION OF THIS INFORMATION HAS BEEN SENT. THIS PATIENT HAD A FT4 RESULT OF 13.36 PMOL/L. PATIENT 26 HAD A CKL VALUE OF 116. THE UNITS OF MEASURE FOR THE CKL ASSAY ARE UNKNOWN. PATIENT 27 HAD A CORTISOL VALUE OF 0.45, BUT IT IS NOT KNOWN IF THIS VALUE ACTUALLY IS A CORTISOL VALUE, IF IT IS AN M1 OR M2 VALUE, IF IT REPRESENTS A THIRD CORTISOL VALUE, OR IF THIS VALUE IS CONVERTED AND CORRESPONDS TO THE M2 VALUE OF 445 UMOL/L ORIGINALLY PROVIDED. A REQUEST FOR CLARIFICATION OF THIS INFORMATION HAS BEEN SENT. PATIENT 28 HAD A TSH RESULT OF 6.17 MU/I. PATIENT 34 HAD A TSH RESULT OF 1.48 MU/I. PATIENT 35 HAD A TSH RESULT OF 5.09 MU/I. FOR PATIENT 36, THE M1 FT4 RESULT OF 100 PMOL/L WAS ACCOMPANIED BY A DATA FLAG. THIS PATIENT HAD A TSH RESULT OF 33.96 MU/I. PATIENT 37 HAD A TSH RESULT OF 27.86 MU/I. PATIENT 41 HAD A FT4 VALUE OF 49.85 PMOL/L. IT IS NOT KNOWN IF THIS IS A THIRD VALUE FROM THE PATIENT OR IF THIS CORRESPONDS TO THE ORIGINAL M1 VALUE OF 49.54 PMOL/L. A REQUEST FOR CLARIFICATION OF THIS INFORMATION HAS BEEN SENT. THIS PATIENT HAD A TSH RESULT OF 3.99 MU/I. FOR PATIENT 42, THE M1 CORTISOL RESULT OF 1750 UMOL/L WAS ACCOMPANIED BY A DATA FLAG. THIS PATIENT HAD A CORTISOL VALUE OF 0.68, BUT IT IS NOT KNOWN IF THIS VALUE ACTUALLY IS A CORTISOL VALUE, IF IT IS AN M1 OR M2 VALUE, IF IT REPRESENTS A THIRD CORTISOL VALUE, OR IF THIS VALUE IS CONVERTED AND CORRESPONDS TO THE M2 VALUE OF 680 UMOL/L ORIGINALLY PROVIDED. A REQUEST FOR CLARIFICATION OF THIS INFORMATION HAS BEEN SENT. THIS PATIENT ALSO HAD A CORTISOL VALUE OF 680.3 UMOL/L, BUT IT IS NOT KNOWN IF THIS VALUE REPRESENTS A FOURTH CORTISOL VALUE OR IF IT CORRESPONDS TO THE ORIGINAL M2 VALUE OF 680 UMOL/L. A REQUEST FOR CLARIFICATION OF THIS INFORMATION HAS BEEN SENT. PATIENT 43 HAD A TSH RESULT OF 2.12 MU/I. PATIENT 44 HAD A TSH RESULT OF 1.44 MU/I. PATIENT 46 HAD A TSH RESULT OF 4.51 MU/I. PATIENT 48 HAD A TSH RESULT OF 0.865 MU/I. THIS PATIENT HAD A CORTISOL VALUE OF 0.36 UMOL/L. PATIENT 49 HAD AN ADDITIONAL CORTISOL VALUE OF 357.8 UMOL/L, BUT IT IS NOT CLEAR IF THIS REPRESENTS A THIRD VALUE OR IF IT CORRESPONDS TO THE ORIGINAL M2 VALUE OF 357.8 UMOL/L. A REQUEST FOR CLARIFICATION OF THIS INFORMATION HAS BEEN SENT. FOR PATIENT 51, THE M1 FT4 RESULT OF 100 PMOL/L WAS ACCOMPANIED BY A DATA FLAG. THIS PATIENT HAD A TSH RESULT OF 0.023 MU/I. THIS PATIENT ALSO HAD A TSH VALUE OF 0.009, BUT IT IS NOT KNOWN IF THIS VALUE ACTUALLY IS A TSHVALUE, IF IT IS AN M1 OR M2 VALUE, OR IF IT REPRESENTS A SECOND TSH VALUE. A REQUEST FOR CLARIFICATION OF THIS INFORMATION HAS BEEN SENT. PATIENT 53 HAD A TSH RESULT OF 3.88 MU/I. FOR PATIENT 54, THE M1 FT4 RESULT OF >100 PMOL/L WAS ACCOMPANIED BY A DATA FLAG. THIS PATIENT HAD A TSH RESULT OF 1.66 MU/I. FOR PATIENT 55, THE M1 FT4 RESULT OF >100 PMOL/L WAS ACCOMPANIED BY A DATA FLAG. THIS PATIENT HAD A TSH RESULT OF 0.041 MU/I. PATIENT 58 HAD A TSH RESULT OF 2.13 MU/I. FOR PATIENT 59, THE M1 FT4 RESULT OF 100 PMOL/L WAS ACCOMPANIED BY A DATA FLAG. THIS PATIENT HAD A TSH RESULT OF 0.904 MU/I. PATIENT 60 HAD A TSH RESULT OF 75.59 MU/I. PATIENT 61 HAD AN ADDITIONAL CORTISOL VALUE OF 410.1 UMOL/L, BUT IT IS NOT CLEAR IF THIS REPRESENTS A THIRD VALUE OR IF IT CORRESPONDS TO THE ORIGINAL M2 VALUE OF 410.1 UMOL/L. A REQUEST FOR CLARIFICATION OF THIS INFORMATION HAS BEEN SENT . THIS PATIENT ALSO HAD AN ADDITIONAL CORTISOL VALUE OF 0.41, BUT IT IS NOT KNOWN IF THIS VALUE ACTUALLY IS A CORTISOL VALUE, IF IT IS AN M1 OR M2 VALUE, IF IT REPRESENTS A FOURTH CORTISOL VALUE, OR IF THIS VALUE IS CONVERTED AND CORRESPONDS TO THE M2 VALUE OF 410.1 UMOL/L ORIGINALLY PROVIDED. A REQUEST FOR CLARIFICATION OF THIS INFORMATION HAS BEEN SENT. PATIENT 63 HAD A TSH RESULT OF 1.85 MU/I. PATIENT 64 HAD A TSH RESULT OF 1.85 MU/I. PATIENT 66 HAD AN ADDITIONAL PTH VALUE OF 11.67 PMOL/L. IT IS NOT KNOWN IF THIS IS A THIRD VALUE FROM THE PATIENT OR IF THIS CORRESPONDS TO THE ORIGINAL M2 VALUE OF 11.67 PMOL/L. A REQUEST FOR CLARIFICATION OF THIS INFORMATION HAS BEEN SENT. FOR PATIENT 71, THE M1 FT4 RESULT OF 100 PMOL/L WAS ACCOMPANIED BY A DATA FLAG. THE M1 ANTI-TPO RESULT WAS 600.0 ACCOMPANIED BY A DATA FLAG. THIS PATIENT HAD A TSH RESULT OF 0.320 MU/I. FOR PATIENT 72, THE M2 TSH VALUE OF 4.43 MAY ACTUALLY BE A PROBNP VALUE INSTEAD OF TSH. THE TSH VALUE FOR M2 MAY ACTUALLY BE 1.99 MU/I, BUT THIS IS NOT CLEAR. A CLARIFICATION HAS BEEN REQUESTED. PATIENT 74 HAD A TSH RESULT OF 0.165 MU/I. PATIENT 75 HAD A TSH RESULT OF 1.70MU/I. FOR PATIENT 76, THE M2 TSH RESULT OF 0.01 MAY ACTUALLY BE <0.01. A CLARIFICATION HAS BEEN REQUESTED. FOR THIS PATIENT, THE M1 FT4 RESULT OF >100 PMOL/L WAS ACCOMPANIED BY A DATA FLAG. PATIENT 78 HAD A TSH RESULT OF 0.408 MU/I. FOR PATIENT 79, THE M1 ANTI-TPO RESULT WAS 600.0 ACCOMPANIED BY A DATA FLAG. THIS PATIENT HAD A TSH RESULT OF 1.50 MU/I. INFORMATION WAS PROVIDED FOR WHAT APPEARS TO BE AN EIGHTIETH PATIENT SAMPLE, BUT IT IS NOT CLEAR IF THESE SAMPLE RESULTS WERE FOR A PATIENT ALREADY PROVIDED OR IF IS AN ADDITIONAL PATIENT SAMPLE. THIS SAMPLE HAD FT4 VALUES OF 98.08 PMOL/L, 98.08 PMOL/L, AND 18.69 PMOL/L. A REQUEST FOR CLARIFICATION HAS BEEN SENT. THE TNT ASSAY USED FOR ALL PATIENTS TESTED FOR TNT IS THE TROPONIN T HIGH SENSITIVE ASSAY, WHICH IS A PRODUCT THAT IS NOT SOLD OR DISTRIBUTED IN THE UNITED STATES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED SEVERAL WRONG MEASUREMENTS WITH MULTIPLE TESTS ON MEASURING CELL ONE OF THE E601 ANALYZER. A TOTAL OF NINETY FOUR SAMPLES WERE QUESTIONED AND SEVENTY NINE WERE FOUND TO HAVE ERRONEOUS RESULTS. ASSAYS TESTED INCLUDE CK-MB THE MB ISOENZYME OF CREATINE KINASE (CKMB), TOTAL (FREE + COMPLEXED) PROSTATE-SPECIFIC ANTIGEN (TPSA) , CORTISOL (CORT), PARATHYROID HORMONE (PTH), TROPONIN T (TNT), ANTIBODIES TO THYROID PEROXIDASE (ANTI TPO), TRIIODOTHYRONINE (T3), THYROTROPIN (TSH), FREE THYROXINE (FT4), AND FREE PSA (FPSA). THE UNITS OF MEASURE FOR ALL ASSAYS ARE UNKNOWN. THIS INFORMATION HAS BEEN REQUESTED. ALL RESULTS FOR ALL SAMPLES WERE REPORTED OUTSIDE OF THE LABORATORY. FOUR PATIENTS WERE AFFECTED BY THE EVENT. THREE WERE SENT TO "SEH DEPARTMENT" AND ONE PATIENT TO THE "CCU". IT IS UNKNOWN WHICH PATIENTS WERE THE ONES THAT WERE AFFECTED AND IT IS UNKNOWN IF THEY WERE IN ANY WAY ADVERSELY AFFECTED BY BEING SENT TO "SEH DEPARTMENT" AND "CCU". THIS INFORMATION HAS BEEN REQUESTED. NO ADVERSE EVENTS WERE ALLEGED. THE REAGENT LOT NUMBERS AND EXPIRATION DATES WERE ASKED FOR, BUT NOT PROVIDED. THE WRONG MEASUREMENTS WERE CAUSED BY AN INSTRUMENT FAILURE BUT THE SPECIFIC FAILURE WAS NOT DESCRIBED. THIS INFORMATION HAS BEEN REQUESTED. LOW LEVEL DETECTION ALARMS FOR THE PROCELL REAGENT WERE OBSERVED. TOO LITTLE ASPIRATION OF PROCELL CAN EXPLAIN THE OBSERVED LOWER VALUES AND THIS CAN BE INCLUDED AS A POSSIBLE ROOT CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339911 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1