BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS FERRITIN

    MDR report key: 16522830 · Received March 10, 2023

    Report

    Report Number
    1823260-2023-00761
    Event Type
    Malfunction
    Date Received
    March 10, 2023
    Date of Event
    February 8, 2023
    Report Date
    April 12, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JMG
    UDI-DI
    04015630939688
    PMA / PMN Number
    K971833
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE QCS WERE IN RANGE. THE LEVEL 1 CALIBRATION AND LEVEL 2 CALIBRATION RESULTS WERE SLIGHTLY BELOW THE APPROXIMATE EXPECTED RANGE. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE MOST OBSERVED ALARM IN THE ALARM TRACE WAS "REAGENT PROBE LIQUID-LEVEL DETECTION (LLD)". THIS SUGGESTS A PRE-ANALYTIC REAGENT HANDLING ISSUE. A GENERAL REAGENT ISSUE WAS NOT IDENTIFIED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS FERRITIN (FERRITIN) RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 ANALYTICAL UNIT WITH SERIAL NUMBER 20X6-04. THE INITIAL RESULT WAS REPORTED TO THE MEDICAL PERSONNEL AND WAS REJECTED AS IT DID NOT FIT THE MEDICAL STATE AND THE PREVIOUS RESULTS OF THE PATIENT. THE INITIAL RESULT OF THE UNDILUTED SAMPLE WAS 64.5 NG/ML. THE FIRST REPEAT RESULT OF THE UNDILUTED SAMPLE WAS 2000 NG/ML WITH A DATA FLAG. THE SECOND REPEAT RESULT USING A DILUTED SAMPLE WAS 4370 NG/ML. THIS REPEAT RESULT WAS DEEMED CORRECT AS IT IS IN LINE WITH THE PREVIOUS RESULTS AND THE CLINICAL PICTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1182126 ELECSYS FERRITIN FERRITIN IMMUNOLOGICAL TEST SYSTEM JMG ROCHE DIAGNOSTICS NA 65213901 04015630939688

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown