BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS FERRITIN

    MDR report key: 11635016 · Received April 8, 2021

    Report

    Report Number
    1823260-2021-01078
    Event Type
    Malfunction
    Date Received
    April 8, 2021
    Date of Event
    March 16, 2021
    Report Date
    June 16, 2021
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JMG
    PMA / PMN Number
    K971833
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE REAGENT PACK IN USE AND THE STANDBY PACK WERE BOTH CALIBRATED ON (B)(6) 2021. THE PACK THAT WAS FIRST IN USE HAD CALIBRATION SIGNALS NOTICEABLY LOWER THAN EXPECTED. THE CALIBRATION SIGNALS FROM THE STANDBY PACK WERE WITHIN EXPECTATIONS. CONTROLS RUN ON (B)(6) 2021 WERE WITHIN SPECIFIED RANGES. UPON REVIEW OF THE ALARM TRACE, SEVERAL ABNORMAL ASPIRATION ALARMS OCCURRED ON THE DAY OF THE EVENT. THIS COULD INDICATE ISSUES RELATED TO SAMPLE QUALITY, BUT LIKELY NOT RELATED TO THE EVENT. THE INVESTIGATION DETERMINED THE ISSUE WAS CONSISTENT WITH POOR CALIBRATION ON THE REAGENT PACK THAT WAS FIRST IN USE. A GENERAL INSTRUMENT ISSUE IS UNLIKELY.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER NOTED THAT CALIBRATION SIGNALS WERE LOW FOR THE REAGENT PACK USED FOR INITIAL TESTING OF THE PATIENT SAMPLES. THE FIELD SERVICE ENGINEER REPLACED THE MEASURING CELL. THE CUSTOMER RAN CALIBRATION AND CONTROLS. MEDWATCH FIELD UDI NUMBER = (B)(4). (B)(6). THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE INITIAL REPORTER STATED THEY HAD ISSUES WITH RECOVERY FOR MANY CONTROLS RUN ON THE COBAS 6000 E 601 MODULE ON (B)(6) 2021. IT WAS DETERMINED THE TEST COUNTS FOR THE MEASURING CELLS WERE HIGH. THE FIELD SERVICE ENGINEER ADJUSTED THE PHOTOMULTIPLIER TUBE HIGH VOLTAGE, RAN SYSTEM VOLUME CHECKS, AND RAN A BLANK CELL CALIBRATION. ON (B)(6) 2021, THE CUSTOMER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED WITH ELECSYS FERRITIN ON THE E 601 ANALYZER. THE REAGENT PACK THAT WAS IN USE WAS REPLACED WITH A STANDBY REAGENT PACK AND THE SAMPLES WERE REPEATED, YIELDING DIFFERENT RESULTS. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE FIRST SAMPLE INITIALLY RESULTED IN A FERRITIN VALUE OF 809.1 NG/ML, WHICH REPEATED AS 428.19 NG/ML. THE SECOND SAMPLE INITIALLY RESULTED IN A FERRITIN VALUE OF 87.63 NG/ML, WHICH REPEATED AS 46.53 NG/ML. THE SERIAL NUMBER OF THE E 601 ANALYZER IS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531302 ELECSYS FERRITIN RADIOIMMUNOASSAY (TWO-SITE SOLID PHASE), FERRITIN JMG ROCHE DIAGNOSTICS NA 49581200

    Patients

    Seq Age Sex Outcome Treatment
    1