BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS FERRITIN

    MDR report key: 20250780 · Received September 18, 2024

    Report

    Report Number
    1823260-2024-02698
    Event Type
    Malfunction
    Date Received
    September 18, 2024
    Date of Event
    July 28, 2024
    Report Date
    October 14, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JMG
    UDI-DI
    04015630938957
    PMA / PMN Number
    K971833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ANALYZER SERIAL NUMBER IS (B)( THE QC WAS ACCEPTABLE ON THE DAY OF THE EVENT. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE MEASURING CELLS, GEAR PUMP, AND BOTH SIPPER PROBES. THE FSE PERFORMED A MECHANICAL CHECK SUCCESSFULLY. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE OF THE EVENT WAS FOUND TO BE CONSISTENT WITH PRE-ANALYTICAL SAMPLE HANDLING ISSUES.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FERRITIN RESULTS FOR 1 PATIENT SERUM SAMPLE ON A COBAS 6000 E601 MODULE. THE INITIAL FERRITIN RESULT WAS 1.33 NG/L. THE CUSTOMER QUESTIONED THE INITIAL RESULT AS IT DID NOT MATCH THE PATIENT'S PREVIOUS RESULT. THE SAMPLE WAS REPEATED AND THE RESULT WAS 988.4 NG/L. THE SAMPLE WAS ALSO REPEATED ON ANOTHER E601 ANALYZER AND THE RESULT WAS 1010 NG/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULTS WERE DEEMED CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2528878 ELECSYS FERRITIN FERRITIN IMMUNOLOGICAL TEST SYSTEM JMG ROCHE DIAGNOSTICS ASKU 04015630938957

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown