BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 ANALYZER (RACK SYSTEM)

    MDR report key: 21313369 · Received February 5, 2025

    Report

    Report Number
    1823260-2025-00342
    Event Type
    Malfunction
    Date Received
    February 5, 2025
    Date of Event
    January 2, 2025
    Report Date
    March 3, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924721
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CALIBRATION RESULTS WERE WITHIN SPECIFICATIONS. THE QCS WERE WITHIN THE -2 STANDARD DEVIATIONS AND WERE ACCEPTABLE. THERE WAS NO INDICATION OF A PERFORMANCE ISSUE WITH THE REAGENT. THE ALARM TRACE DID NOT INDICATE ANY ISSUES. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Additional Manufacturer Narrative · 0

    THE ESTRADIOL III REAGENT LOT NUMBER IS 792358. THE VITAMIN D TOTAL III REAGENT LOT NUMBER IS 786890. THE EXPIRATION DATES WERE NOT PROVIDED. THE FIELD SERVICE ENGINEER INSPECTED THE ANALYZER BUT COULD NOT ESTABLISH THE EVENT'S CAUSE. HE PERFORMED AN INSTRUMENT CHECK AND ADJUSTED THE SAMPLE/REAGENT PROBES AND MIXER PADDLE. HE VERIFIED THE CALIBRATION TRACE WAS ACCORDING TO SPECIFICATIONS. HE VERIFIED THE ANALYZER'S PERFORMANCE WITH ANOTHER INSTRUMENT CHECK, PRECISION CHECKS, AND QCS. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS ESTRADIOL III AND ELECSYS VITAMIN D TOTAL G3 (VITD3) RESULTS FROM THREE PATIENT SAMPLES TESTED ON THE COBAS E 411 ANALYZER (RACK SYSTEM). SAMPLE 1 THE INITIAL ESTRADIOL III RESULT WAS 886.4 PG/ML. THE REPEAT RESULT WAS 43.59 PG/ML. SAMPLE 2 THE INITIAL ESTRADIOL III RESULT WAS >3000 PG/ML. THE REPEAT RESULT WAS 284.5 PG/ML. THE INITIAL VITAMIN D TOTAL III RESULT WAS >120 NG/ML. THE REPEAT RESULT WAS 27.46 NG/ML. SAMPLE 3 THE INITIAL ESTRADIOL III RESULT WAS 2776 PG/ML. THE REPEAT RESULT WAS 247.1 PG/ML. THE DOCTOR REQUESTED FOR RERUNS OF THE PATIENT SAMPLES. DATA FLAGS ACCOMPANIED SOME OF THE RESULTS. THE REPEAT RESULTS WERE DEEMED CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61467 COBAS E 411 ANALYZER (RACK SYSTEM) IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E 411 04015630924721

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female