BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 801 ANALYTICAL UNIT

    MDR report key: 20654141 · Received November 11, 2024

    Report

    Report Number
    1823260-2024-03259
    Event Type
    Malfunction
    Date Received
    November 11, 2024
    Date of Event
    October 15, 2024
    Report Date
    December 23, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CALIBRATION DATA WAS ACCEPTABLE. THERE WAS NO INDICATION OF A REAGENT OR INSTRUMENT PERFORMANCE ISSUE. UPON REVIEW OF THE ALARM TRACE, MULTIPLE SAMPLE SHORT AND SAMPLE CLOT DETECTION ALARMS WERE NOTED ON THE DAY OF THE EVENT NEAR THE TIME THE SAMPLE WAS PROCESSED. THE FIELD SERVICE ENGINEER PERFORMED PREVENTIVE MAINTENANCE ON THE ANALYZER. PERFORMANCE TESTING PASSED. A BLANK CELL CALIBRATION WAS PERFORMED. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER IS 801714. THE EXPIRATION DATE WAS NOT PROVIDED. THE QC RECOVERY DATA PROVIDED WAS ACCEPTABLE. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS PTH IMMUNOASSAY RESULTS FOR 1 PATIENT PLASMA SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL PTH RESULT WAS 10 PG/ML. THE DOCTOR QUESTIONED THE RESULT WHICH PROMPTED THE CUSTOMER TO REPEAT THE SAMPLE. THE SAMPLE WAS REPEATED AND THE RESULT WAS 29 PG/ML. THE SAMPLE WAS ALSO REPEATED ON ANOTHER E801 ANALYZER AND THE RESULT WAS 28 PG/ML. THE REPEAT RESULTS WERE DEEMED CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1819524 COBAS E 801 ANALYTICAL UNIT IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E801

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown