BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 IMMUNOASSAY ANALYZER

    MDR report key: 6540235 · Received May 3, 2017

    Report

    Report Number
    1823260-2017-00940
    Event Type
    Malfunction
    Date Received
    May 3, 2017
    Date of Event
    April 14, 2017
    Report Date
    May 17, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE CUSTOMER MENTIONED THAT THEY RECEIVED FURTHER ERRONEOUS LOW TSH RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES. THESE SAMPLES HAD THE SAME ISSUE, INITIALLY RESULTING AS 0.03 MIU/L AND REPEATING AS APPROXIMATELY 3 MIU/L. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AND THERE WAS NO ALLEGATION OF AN ADVERSE EVENT OCCURRING FOR THESE PATIENTS. NO FURTHER DETAILS WERE PROVIDED CONCERNING THESE SAMPLES. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. ADDITIONAL INFORMATION REQUIRED FOR THE INVESTIGATION WAS REQUESTED, BUT NOT PROVIDED. QUALITY CONTROLS WERE WITHIN RANGE. NOT EVERY CONTROL LEVEL WAS TESTED EACH DAY. BASED ON ANALYSIS OF CONTROL AND CALIBRATION DATA, A GENERAL REAGENT ISSUE CAN MOST LIKELY BE EXCLUDED. POSSIBLE ROOT CAUSES ARE BUBBLES/FOAM ON THE SAMPLE SURFACE, NON-USE OF RECOMMENDED RACK ADAPTERS FOR 13 MM TUBES, INSUFFICIENT SAMPLE VOLUME, THE PRESENCE OF DROPLETS ON THE TUBE WALL CAUSING PREMATURE LIQUID LEVEL DETECTION, SAMPLE QUALITY, OR INSUFFICIENT MAINTENANCE. CONCERNING THE DIFFERENCE IN TSH VALUES FROM DIFFERENT SAMPLE COLLECTIONS, CIRCADIAN VARIANCE AND STRESS CAN CAUSE TSH VALUES THAT ARE HIGHER THAN EXPECTED. DIFFERENCES IN VALUES MAY ALSO BE CAUSED BY A SAMPLE HANDLING ISSUE OR REAGENT HANDLING ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR ONE PATIENT SAMPLE TESTED FOR THE ELECSYS TSH ASSAY (TSH) ON A COBAS E 411 IMMUNOASSAY ANALYZER. THE SAMPLE TUBE WAS TESTED AND INITIALLY RESULTED AS 0.030 MIU/L ACCOMPANIED BY A DATA FLAG AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY TO THE DOCTOR. THE DOCTOR WAS NOT SATISFIED WITH THE RESULT, SO HE REQUESTED A REPEAT OF THE SAMPLE. THE SAMPLE TUBE WAS REPEATED ON (B)(6) 2017, RESULTING AS 0.034 MIU/L ACCOMPANIED BY A DATA FLAG. THE REPEAT RESULT OF 0.034 MIU/L WAS ALSO REPORTED OUTSIDE OF THE LABORATORY TO THE DOCTOR AND HE WAS STILL NOT HAPPY WITH THIS RESULT. THE SAMPLE WAS THEN REPEATED IN A CUP ON (B)(6) 2017, RESULTING AS 3.12 MIU/L. THE SAMPLE WAS REPEATED ON (B)(6) 2017, RESULTING AS 3.15 MIU/L. A ROCHE FIELD EMPLOYEE REPEATED THE SAMPLE ON (B)(6) 2017, RESULTING AS 2.96 MIU/L. THE FIELD EMPLOYEE STATED THAT THERE WAS A SMALL VOLUME OF SAMPLE LEFT IN THE TUBE, BUT NO SAMPLE SHORT ALARMS WERE GENERATED. A SECOND SAMPLE WAS COLLECTED FROM THE PATIENT AND TESTED ON (B)(6) 2017, RESULTING AS 1.32 MIU/L. THIS SAMPLE WAS REPEATED ON (B)(6)2017, RESULTING AS 1.34. THIS SAMPLE WAS REPEATED ON (B)(6) 2017 AND RESULTED AS 1.37 MIU/L. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE TSH REAGENT LOT NUMBER WAS 212491. THE REAGENT EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED. THE CALIBRATION WAS VALID AND QUALITY CONTROLS PASSED. THE SAME REAGENT PACK WAS USED FOR ALL SAMPLE MEASUREMENTS. PRECISION STUDIES WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322168 COBAS E 411 IMMUNOASSAY ANALYZER IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E411 RACK NA

    Patients

    Seq Age Sex Outcome Treatment
    1