BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1883240 · Received October 26, 2010

    Report

    Report Number
    1823260-2010-06370
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    October 8, 2010
    Report Date
    December 22, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. INSTRUMENT AND ASSAY PERFORMANCE CHECKS PERFORMED ON THE ANALYZER WERE WITHIN SPECIFICATION AND DO NOT INDICATE AN ISSUE. CALIBRATION AND QUALITY CONTROLS RUN AT THE TIME OF THE EVENT WERE WITHIN SPECIFIED RANGES. THE FIELD SERVICE REPRESENTATIVE ALSO PERFORMED AN ANALYZER COMPARISON STUDY BETWEEN THE ANALYZER AND A REFERENCE ANALYZER, COBAS E601, WHICH SHOWED A GOOD CORRELATION.

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE TROPONIN T RESULTS FOR PATIENT SAMPLES WHICH WERE DISCOVERED WHEN PHYSICIANS QUESTIONED THE RESULTS FOR TWO PATIENT SAMPLES. OF THE DATA PROVIDED, THE RESULTS FOR 18 PATIENT SAMPLES WERE DISCREPANT. ALL REPEAT TESTING WAS PERFORMED ON (B)(6) 2010 ON THE SAME ELECSYS ANALYZER AND A COBAS E601 ANALYZER. ALL RESULTS ARE IN NG/ML. PATIENT SAMPLE 1 INITIAL RESULT WAS 0.06 AND THE REPEAT RESULTS WERE <0.010. PATIENT SAMPLE 2 WAS FROM A FEMALE BORN ON (B)(6). THE INITIAL RESULT WAS 0.06 AND THE REPEAT RESULTS WERE <0.010. PATIENT SAMPLE 3 WAS FROM A FEMALE BORN ON (B)(6). THE INITIAL RESULT WAS 0.07 AND THE REPEAT RESULTS WERE <0.010. PATIENT SAMPLE 4 WAS FROM A FEMALE BORN ON (B)(6). THE INITIAL RESULT WAS 0.07 AND THE REPEAT RESULTS WERE <0.010. PATIENT SAMPLE 5 WAS FROM A MALE BORN ON (B)(6). THE INITIAL RESULT WAS 0.06 AND THE REPEAT RESULTS WERE <0.010. PATIENT SAMPLE 6 WAS FROM A FEMALE BORN ON (B)(6). THE INITIAL RESULT WAS 0.08 AND THE REPEAT RESULTS WERE <0.010. PATIENT SAMPLE 7 WAS FROM A FEMALE BORN ON (B)(6). THE INITIAL RESULT WAS 0.09 AND THE REPEAT RESULTS WERE <0.010. PATIENT SAMPLE 8 WAS FROM A FEMALE BORN ON (B)(6). THE INITIAL RESULT WAS 0.08 AND THE REPEAT RESULTS WERE <0.010. PATIENT SAMPLE 9 WAS FROM A FEMALE BORN ON (B)(6). THE INITIAL RESULT WAS 0.06 AND THE REPEAT RESULTS WERE <0.010. PATIENT SAMPLE 10 WAS FROM A MALE BORN ON (B)(6). THE INITIAL RESULT WAS 0.06 AND THE REPEAT RESULTS WERE <0.010. PATIENT SAMPLE 11 WAS FROM A FEMALE BORN ON (B)(6). THE INITIAL RESULT WAS 0.07 AND THE REPEAT RESULTS WERE <0.010. PATIENT SAMPLE 12 WAS FROM A FEMALE BORN ON (B)(6). THE INITIAL RESULT WAS 0.06 AND THE REPEAT RESULTS WERE <0.010. PATIENT SAMPLE 13 WAS FROM A MALE BORN ON (B)(6). THE INITIAL RESULT WAS 0.06 AND THE REPEAT RESULTS WERE <0.010. PATIENT SAMPLE 14 WAS FROM A MALE BORN ON (B)(6). THE INITIAL RESULT WAS 0.07 AND THE REPEAT RESULTS WERE <0.010. PATIENT SAMPLE 15 WAS FROM A FEMALE BORN ON (B)(6). THE INITIAL RESULT WAS 0.13 AND THE REPEAT RESULTS WERE 0.056 AND 0.055. PATIENT SAMPLE 16 WAS FROM A MALE BORN ON (B)(6). THE INITIAL RESULT WAS 0.10 AND THE REPEAT RESULTS WERE 0.024 AND 0.031. PATIENT SAMPLE 17 WAS FROM A MALE BORN ON (B)(6). THE INITIAL RESULT WAS 0.16 AND THE REPEAT RESULTS WERE 0.092 AND 0.086. PATIENT SAMPLE 18 WAS FROM A MALE BORN ON (B)(6). THE INITIAL RESULT ON (B)(6) 2010 WAS 0.02 AND THE REPEAT RESULTS WERE 0.023 AND 0.019. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE PATIENT FOR SAMPLE 2 WAS SENT TO THE "CATH LAB" FOR A CATHETERIZATION BASED ON THE ERRONEOUS RESULT. THE PATIENT WAS NOT ADVERSELY AFFECTED AND WAS DISCHARGED ON (B)(6) 2010. NO ADVERSE EVENTS WERE ALLEGED FOR THE OTHER PATIENTS. THE TROPONIN T REAGENT LOT NUMBER WAS 15887701. THE FIELD SERVICE REPRESENTATIVE COULD NOT FIND A CAUSE. HE INSPECTED THE INSTRUMENT FUNCTIONALITY, MONITORED THE SAMPLE, REAGENT AND SIPPER ASPIRATION AND PIPETTING, VERIFIED THE SIPPER RINSE AND INSPECTED THE REAGENT PACKS. TO VERIFY THE ANALYZER OPERATION, CALIBRATION AND QUALITY CONTROL WERE TESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECSYS 2010 RACK IMMUNOCHEMISTRY ANALYZER MMI ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 078 YR