BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS ESTRADIOL III

    MDR report key: 20522306 · Received October 24, 2024

    Report

    Report Number
    1823260-2024-03059
    Event Type
    Malfunction
    Date Received
    October 24, 2024
    Date of Event
    September 27, 2024
    Report Date
    December 5, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CHP
    UDI-DI
    04015630933358
    PMA / PMN Number
    K965109
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE CUSTOMER'S COBAS E411 DISK IS (B)(6). THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER STATED THAT THEY HAD NO ISSUES WITH THE REAGENT QC. THE FIELD APPLICATIONS SPECIALIST NOTED THAT THE IMPRECISION IN THE LIMIT OF DETECTION (LOD) MEASUREMENT WAS DUE TO THE ANALYTIC MEASURABLE RANGE (AMR) BEING SET TO THE LOD OF THE ASSAY INSTEAD OF THE LIMIT OF QUANTIFICATION (LOQ). PRODUCT LABELING STATES "LIMIT OF DETECTION: 18.4 PMOL/L (5 PG/ML); LIMIT OF QUANTITATION: 91.8 PMOL/L (25 PG/ML) WITH A TOTAL ALLOWABLE ERROR OF 30 %." THE CUSTOMER PERFORMED A CORRELATION TEST WITH SUCCESSFUL RESULTS. THE CUSTOMER STATED THERE WERE NO ISSUES WITH THE ANALYZER.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS ESTRADIOL III RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E411 DISK. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY AS THE REPORTER QUESTIONED IT, PROMPTING THE RERUN OF THE PATIENT SAMPLE. THE INITIAL RESULT OF THE UNDILUTED PATIENT SAMPLE WAS >3000 PG/ML WITH A DATA FLAG. THE FIRST REPEAT RESULT OF THE ANALYZER-DILUTED PATIENT SAMPLE WAS AN ESTIMATED RESULT OF 256/270 PG/ML. THE SECOND REPEAT RESULT OF THE UNDILUTED PATIENT SAMPLE WAS 16 PG/ML. THE THIRD REPEAT RESULT OF THE UNDILUTED PATIENT SAMPLE WAS 11.18 PG/ML. THE FOURTH REPEAT RESULT FROM ANOTHER LABORATORY THAT USES A COBAS E 801 ANALYZER WAS <5 PG/ML WITH A DATA FLAG. THIS RESULT WAS DEEMED CORRECT AND REPORTED, AS THE DOCTOR EXPECTED A "<30" RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2564842 ELECSYS ESTRADIOL III RADIOIMMUNOASSY, ESTRADIOL CHP ROCHE DIAGNOSTICS ASKU 04015630933358

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female