BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS HGH

    MDR report key: 21785472 · Received April 7, 2025

    Report

    Report Number
    1823260-2025-01034
    Event Type
    Malfunction
    Date Received
    April 7, 2025
    Date of Event
    November 11, 2023
    Report Date
    June 3, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE CUSTOMER'S E801 ANALYZER IS (B)(6). THE SERIAL NUMBER OF THE E801 ANALYZER USED FOR INVESTIGATION WAS REQUESTED, BUT NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    AN ASSESSMENT OF THE COMPLAINT WAS PERFORMED BY A ROCHE PHYSICIAN. THE PHYSICIAN CONCLUDED THAT WHILE THE RESULTS MAY INITIALLY APPEAR INCONSISTENT, THIS PATTERN IS WELL-RECOGNIZED IN PATIENTS WITH ACROMEGALY, PARTICULARLY THOSE UNDERGOING TREATMENT. IGF-1 AND HGH ARE PHYSIOLOGICALLY RELATED BUT BEHAVE DIFFERENTLY IN CLINICAL MEASUREMENTS: IGF-1 IS THE MORE STABLE AND RELIABLE MARKER, WITH MINIMAL DIURNAL VARIATION, AND IS THE PRIMARY BIOMARKER RECOMMENDED FOR MONITORING DISEASE ACTIVITY, AS PER CURRENT CLINICAL GUIDELINES. HGH, DUE TO ITS PULSATILE SECRETION PATTERN, MAY BE LOW IN RANDOM MEASUREMENTS AND IS NOT ALWAYS REFLECTIVE OF THE TRUE DISEASE STATUS. RANDOM HGH LEVELS ARE NOT A RELIABLE STANDALONE MARKER DUE TO SECRETION VARIABILITY AND MEDICATION EFFECTS. CURRENT BEST PRACTICE EMPHASIZES IGF-1 AS THE CORNERSTONE OF MONITORING DISEASE ACTIVITY AND GUIDING TREATMENT ADJUSTMENTS. IN THIS CASE, THE PERSISTENTLY ELEVATED IGF-1, WELL ABOVE THE UPPER LIMIT OF NORMAL, REMAINS CLINICALLY SIGNIFICANT AND IS CONSISTENT WITH ONGOING HGH EXCESS, EVEN IF THE HGH LEVEL APPEARS LOW IN A SINGLE MEASUREMENT. THIS IS CONSISTENT WITH BIOCHEMICALLY ACTIVE ACROMEGALY AND WARRANTS FURTHER CLINICAL CONSIDERATION. THE INVESTIGATION CONCLUDES THERE IS NO MALFUNCTION OF THE DEVICE. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED INCONSISTENT RESULTS FOR 6 SAMPLES COLLECTED FROM THE SAME PATIENT AND TESTED WITH ELECSYS IGF-1 AND ELECSYS HGH ON A COBAS E 801 ANALYTICAL UNIT. THE FIFTH PATIENT SAMPLE WAS ALSO MEASURED ON A SECOND E 801 ANALYZER USED FOR INVESTIGATION. THE PATIENT HAS ACROMEGALY AND THE CUSTOMER BELIEVES THAT BOTH HGH AND IGF-1 VALUES SHOULD BOTH BE INCREASED. THE CUSTOMER DID NOT KNOW IF THE HGH VALUES WERE FALSELY LOW OR IF THE IGF-1 VALUES WERE FALSELY HIGH. THIS MEDWATCH WILL COVER THE ELECSYS HGH ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ELECSYS IGF-1 ASSAY. THE FIRST SAMPLE MEASURED ON (B)(6) 2023 RESULTED IN AN HGH VALUE OF 0.65 NG/ML AND AN IGF-1 VALUE OF 401 NG/ML. THE SECOND SAMPLE MEASURED ON (B)(6) 2024 RESULTED IN AN HGH VALUE OF 0.72 NG/ML AND AN IGF-1 VALUE OF 408 NG/ML. THE THIRD SAMPLE MEASURED ON (B)(6) 2024 RESULTED IN AN HGH VALUE OF 1.04 NG/ML AND AN IGF-1 VALUE OF 387 NG/ML. THE FOURTH SAMPLE MEASURED ON (B)(6) 2024 RESULTED IN AN HGH VALUE OF 0.55 NG/ML AND AN IGF-1 VALUE OF 355 NG/ML. THE FIFTH SAMPLE MEASURED ON (B)(6) 2024 RESULTED IN AN HGH VALUE OF 0.64 NG/ML AND AN IGF-1 VALUE OF 424 NG/ML. THIS SAMPLE WAS PROVIDED FOR INVESTIGATION WHERE IT WAS REPEATED ON A SECOND E801 ANALYZER ON (B)(6) 2025, RESULTING IN AN HGH VALUE OF 0.718 NG/ML AND AN IGF-1 VALUE OF 448 NG/ML. THE SIXTH SAMPLE MEASURED ON (B)(6) 2025 RESULTED IN AN HGH VALUE OF 0.95 NG/ML AND AN IGF-1 VALUE OF 429 NG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1570019 ELECSYS HGH HUMAN GROWTH HORMONE ASSAY CFL ROCHE DIAGNOSTICS ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male