MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS IGF-1; HUMAN GROWTH HORMONE ASSAY

Catalog Number	07475896190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2017
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation of discrepancies between the elecsys igf-1 measurements from the cobas e411 analyzer when compared with the results from an immulite 2000xpi siemens healthcare diagnostics analyzer, and when correlated with the clinical course of several patients from a journal article "beyond the method change in clinical practice: evaluation of insulin-like growth factor i assay" by paula sienes bailo, marta fabre estremera, josé cuenca alcocel, and maría ángeles césar márquez, published online on 23-aug 2022.The journal article is attached to this medwatch.The journal stated that within months after a laboratory changed their assay from the immulite 2000xpi, with an enzyme-labelled chemiluminescent immunometric assay laboratory method to the cobas e411 with an electrochemiluminescence immunoassay laboratory method, they have observed a suspiciously high proportion of samples with igf-1 concentrations above the age- and sex-specific reference intervals (ris) provided by the roche diagnostics and that clinicians also observed discrepancies between igf-1 measurements by cobas e411 and the clinical course of several patients; the igf-1 results measured by the cobas e411 were generally higher than those of immulite 2000xpi.The journal provided an example of one patient with discrepant results from the cobas (b)(6) analyzer.Please refer to the attachment (b)(6) in the medwatch for the table containing the patient's comparison results between the two analyzers.
Additional Manufacturer Narrative
The investigation is ongoing.

• Brand Name: ELECSYS IGF-1
• Common Device Name: HUMAN GROWTH HORMONE ASSAY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 24507783
• Report Number: 1823260-2026-00762
• Device Sequence Number: 16066424
• Product Code: CFL
• UDI-Device Identifier: 07613336143131
• UDI-Public: 07613336143131
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 07475896190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2026
• Supplement Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RHGH TREATMENT
• Patient Age: 12 YR
• Patient Sex: Female