BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS IGF-1

    MDR report key: 21663127 · Received March 21, 2025

    Report

    Report Number
    1823260-2025-00823
    Event Type
    Malfunction
    Date Received
    March 21, 2025
    Date of Event
    February 26, 2025
    Report Date
    July 3, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CFL
    UDI-DI
    07613336143131
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THROUGH INVESTIGATION, A STANDARDIZATION ISSUE IN THE IGF-1 ASSAY WAS IDENTIFIED. IN THIS SPECIFIC SITUATION, IT HAS BEEN OBSERVED THAT IG-F MEASUREMENTS FOR PATIENTS PRESENTING IGF-1 CONCENTRATIONS IN THE HIGH MEASURING RANGE (IGF-1 > 800 NG/ML) MIGHT LEAD TO INCREASED IGF-1 RESULTS: THE PLUS BIAS STARTS AT AROUND IGF-1 800 NG/ML AND INCREASES PROGRESSIVELY UP TO CIRCA 25% AT IGF-1 1600 NG/ML. ACCORDING TO GOOD CLINICAL PRACTICE, THE MEDICAL DECISION ATTRIBUTABLE TO POTENTIAL IGF-1 INCORRECT TEST RESULTS DEPENDS SIGNIFICANTLY ON THE CONSTELLATION OF DIAGNOSTIC AND CLINICAL PARAMETERS SUCH AS THE DEGREE OF ANALYTICAL VARIATION OF AFFECTED RESULTS, SPECIFIC AFFECTED RANGE, DETECTABILITY BY TECHNICAL INDICES, DETECTABILITY DUE TO CLINICAL IMPLAUSIBILITY, ADDITIONAL DIAGNOSTIC TESTING RESULTS AND CONGRUENCE OF THE OVERALL CLINICAL PICTURE. THUS, BOTH THE IGF-1 VALUES (OBTAINED INCREASED IGF-1 AND TRUE IGF-1) ARE CLEARLY ABOVE THE UPPER END OF THE NORMAL RANGE FOR IGF-1 EXPECTED VALUES. TOGETHER, IN THE POTENTIAL CLINICAL SCENARIOS, IT IS UNLIKELY THAT CLINICAL CARE COULD BE SIGNIFICANTLY INFLUENCED BY THE OBSERVED ISSUE.

    Additional Manufacturer Narrative · 0

    THE COBAS E 801 ANALYTICAL UNIT SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS IGF-1 RESULT FROM THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS > 1600 NG/ML. THE FOLLOWING ARE THE RESULTS AFTER DILUTION: A DILUTION OF 1:10 WITH A RESULT OF 1157 NG/ML. A DILUTION OF 1:5 WITH A RESULT OF 1198 NG/ML. A DILUTION OF 1:2 WITH A RESULT OF 1143 NG/ML. A MANUAL DILUTION OF 1:10 WITH A RESULT OF 1153 NG/ML. A MANUAL DILUTION OF 1:5 WITH A RESULT OF 1170 NG/ML THERE WAS A PRECIPITATION RESULT OF 1243 NG/ML. THEY COMPARED THE RESULTS TO A SIMENS ANALYZER WITH A RESULT OF 640 NG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561456 ELECSYS IGF-1 HUMAN GROWTH HORMONE ASSAY CFL ROCHE DIAGNOSTICS 81739901 07613336143131

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Male GENSCI'S POLYETHYLENE GLYCOL