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	02/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 411 analyzer (rack system) serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys igf-1 assay results from eight patient samples tested on the cobas e 411 analyzer (rack system).The reporter stated that clinicians are questioning the elecsys igf-1 results obtained from the analyzer, as they are higher than those from the immulite analyzer.The following are representative examples of two patient samples with discrepant results from the list of eight patient samples provided: patient sample 1.The result from the analyzer is 492 ug/l.The result from the immulite analyzer is 342 ug/l.Patient sample 2.The result from the analyzer is 603 ug/l.The result from the immulite analyzer is 456 ug/l.
Additional Manufacturer Narrative
On (b)(6) 2026, the customer reported new, questionable elecsys igf-1 assay results for five patient samples tested on the cobas e 411 analyzer (rack system) and the cobas e 801 analyzer.From the five patient sample comparison results provided, one patient sample was found to have discrepant results: patient sample 3 the result from the e 411 analyzer is 707 ug/l.The result from the e 801 analyzer is 715 ug/l.The result from the immulite analyzer is 471 ug/l.The cobas e 801 analyzer serial number was not provided.Medwatch field b7 other relevant history updated.

• 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: 24486886
• Report Number: 1823260-2026-00740
• Device Sequence Number: 10666255
• Product Code: CFL
• UDI-Device Identifier: 07613336143131
• UDI-Public: 07613336143131
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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 Expiration Date: 08/31/2026
• Device Catalogue Number: 07475896190
• Device Lot Number: 912815
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2026
• Supplement Date Received by Manufacturer: 03/06/2026; 04/13/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 04/02/2026; 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
• Patient Sex: Unknown