BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 801 ANALYTICAL UNIT

    MDR report key: 20245347 · Received September 18, 2024

    Report

    Report Number
    1823260-2024-02694
    Event Type
    Malfunction
    Date Received
    September 18, 2024
    Date of Event
    August 29, 2024
    Report Date
    October 30, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ESTRADIOL REAGENT LOT NUMBER IS 791017, THE FSH REAGENT LOT NUMBER IS 766311, THE PROLACTIN REAGENT LOT NUMBER IS 765079, AND THE TESTOSTERONE REAGENT LOT NUMBER IS 752625. THE REAGENT EXPIRATION DATES WERE REQUESTED, BUT NOT PROVIDED. THE SAMPLE PROBE WAS REPLACED AND THE INSTRUMENT WAS WORKING CORRECTLY AGAIN AFTER THIS ACTION. ONE LEVEL OF CONTROL WAS TESTED AND WAS ACCEPTABLE. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE ISSUE IS CONSISTENT WITH INSUFFICIENT PRE-ANALYTIC SAMPLE HANDLING, BUT A HARDWARE ISSUE COULD NOT BE RULED OUT.

    Additional Manufacturer Narrative · 0

    DISCREPANT RESULTS WERE PROVIDED FOR AN ADDITIONAL 7 PATIENT SAMPLES (PATIENTS 5 - 11) TESTED FOR ESTRADIOL, FSH, TESTOSTERONE, AND PROLACTIN. NO UNITS OF MEASURE WERE PROVIDED FOR THE FSH, PROLACTIN, AND TESTOSTERONE ASSAYS. PATIENT (B)(6) INITIAL ESTRADIOL RESULT WAS < 5 PG/ML. THE REPEAT RESULTS FROM A DIFFERENT ANALYZER WERE 217 PG/ML, 180 PG/ML, AND 187 PG/ML. PATIENT (B)(6) INITIAL ESTRADIOL RESULT WAS 53.4 PG/ML. THE REPEAT RESULTS FROM A DIFFERENT ANALYZER WERE 185 PG/ML AND 191 PG/ML. THE INITIAL FSH RESULT WAS 4.16. THE REPEAT RESULTS FROM A DIFFERENT ANALYZER WERE 9.8 AND 9.79. PATIENT (B)(6) INITIAL ESTRADIOL RESULT WAS 126 PG/ML. THE REPEAT RESULT FROM THE SAME ANALYZER WAS 184 PG/ML. THE REPEAT RESULT FROM A DIFFERENT ANALYZER WAS 245 PG/ML. PATIENT (B)(6) INITIAL ESTRADIOL RESULT WAS 19.2 PG/ML. THE REPEAT RESULT FROM THE SAME ANALYZER WAS 24.9 PG/ML. THE REPEAT RESULT FROM A DIFFERENT ANALYZER WAS 37.1 PG/ML. THE INITIAL FSH RESULT WAS 5.49. THE REPEAT RESULT FROM THE SAME ANALYZER WAS 5.1. THE REPEAT RESULT FROM A DIFFERENT ANALYZER WAS 6.78. PATIENT (B)(6) INITIAL ESTRADIOL RESULT WAS 236 PG/ML. THE REPEAT RESULT FROM THE SAME ANALYZER WAS 358 PG/ML. THE REPEAT RESULT FROM A DIFFERENT ANALYZER WAS 429 PG/ML. PATIENT (B)(6) INITIAL ESTRADIOL RESULT WAS 31.9 PG/ML. THE REPEAT RESULT FROM THE SAME ANALYZER WAS 38.7 PG/ML. THE REPEAT RESULT FROM A DIFFERENT ANALYZER WAS 42.7 PG/ML. THE INITIAL FSH RESULT WAS 12. THE REPEAT RESULT FROM THE SAME ANALYZER WAS 20.1. THE REPEAT RESULT FROM A DIFFERENT ANALYZER WAS 20.4. PATIENT (B)(6) INITIAL TESTOSTERONE RESULT WAS 1.63. THE REPEAT RESULT FROM THE SAME ANALYZER WAS 5.73. THE REPEAT RESULT FROM A DIFFERENT ANALYZER WAS 7.9. THE INITIAL PROLACTIN RESULT WAS 5.82. THE REPEAT RESULT FROM THE SAME ANALYZER WAS 6.8. THE REPEAT RESULT FROM A DIFFERENT ANALYZER WAS 9.29. THE INITIAL FSH RESULT WAS 2.93. THE REPEAT RESULT FROM THE SAME ANALYZER WAS 3.72. THE REPEAT RESULT FROM A DIFFERENT ANALYZER WAS 5.2.

    Additional Manufacturer Narrative · 0

    THE ALARM TRACE SHOWED A SAMPLE CLOT ALARM OCCURRING IN THE MORNING BEFORE THE MEASUREMENTS. THE INVESTIGATION DETERMINED THE ISSUE WAS RESOLVED BY THE PROBE REPLACEMENT.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR FOUR PATIENT SAMPLES TESTED ON A COBAS E 801 ANALYTICAL UNIT. RESULTS FOR THE FOLLOWING TESTS WERE AFFECTED: ELECSYS ESTRADIOL III, ELECSYS FSH, ELECSYS PROLACTIN, AND ELECSYS TESTOSTERONE. NO UNITS OF MEASURE WERE PROVIDED FOR THE FSH, PROLACTIN, AND TESTOSTERONE ASSAYS. THE INITIAL VALUES DID NOT AGREE WITH THE CLINICAL DIAGNOSIS OF THE PATIENTS, SO THE SAMPLES WERE REPEATED. THE FIRST SAMPLE INITIALLY RESULTED IN AN ESTRADIOL VALUE OF < 5 PG/ML. THE SAMPLE WAS REPEATED ON A SECOND ANALYZER, RESULTING IN AN ESTRADIOL VALUE OF 217 PG/ML. THE SECOND SAMPLE RESULTED IN THE FOLLOWING VALUES WHEN TESTED ON THE COMPLAINED ANALYZER: ESTRADIOL = 24.9 PG/ML. FSH = 5.10. THE SECOND SAMPLE RESULTED IN THE FOLLOWING VALUES WHEN TESTED ON THE SECOND ANALYZER: ESTRADIOL = 37.1 PG/ML. FSH = 6.78. THE THIRD SAMPLE RESULTED IN AN ESTRADIOL VALUE OF 184 PG/ML WHEN TESTED ON THE COMPLAINED ANALYZER. THE SAMPLE RESULTED IN AN ESTRADIOL VALUE OF 245 PG/ML WHEN TESTED ON THE SECOND ANALYZER. THE FOURTH SAMPLE RESULTED IN THE FOLLOWING VALUES WHEN TESTED ON THE COMPLAINED ANALYZER: ESTRADIOL = 12.0 PG/ML, FSH = 3.72, PROLACTIN = 6.80, TESTOSTERONE = 5.73. THE FOURTH SAMPLE RESULTED IN THE FOLLOWING VALUES WHEN TESTED ON THE SECOND ANALYZER: ESTRADIOL = 19.8 PG/ML, FSH = 5.20, PROLACTIN = 9.29, TESTOSTERONE = 7.90.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1235415 COBAS E 801 ANALYTICAL UNIT IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown