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

Catalog Number	07475918190
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The e801 module serial number was (b)(6).
Event or Problem Description
The initial reporter complained of high results for multiple patient samples tested for elecsys igf-1 (igf-1) starting at the beginning of (b)(6) 2025 on a cobas 8000 e 801 module.The customer had previously used the immulite instrument, and the igf-1 results were lower.An example of questionable results was provided for 1 patient sample.On (b)(6) 2025, the result from the siemens method was 706.0 ng/ml.On (b)(6) 2025, the result from the e801 module was 1107 ng/ml.The repeat result was 1153 ng/ml.The patient had a previous result (b)(6) 2025) from the immulite instrument of 673 ng/ml.
Additional Manufacturer Narrative
The roche and siemens methods are not comparable.Internal investigations determined a calibration issue with the elecsys igf-1 assay, leading to elevated results in patient samples with very high igf-1 concentrations (between 800 ng/ml and 1600 ng/ml).Diluted results more accurately reflect the true igf-1 concentration.There was no issue with igf-1 results <800 ng/ml.The calibration issue was corrected, and customers were advised to change to the new lot numbers 912807 and 912815.However, even with the new lot numbers, the roche results would remain different from the siemens results as the methods are not comparable.

• Brand Name: ELECSYS IGF-1
• Common Device Name: RADIOIMMUNOASSAY, HUMAN GROWTH HORMONE
• 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: 23450187
• Report Number: 1823260-2025-04457
• Device Sequence Number: 9008043
• Product Code: CFL
• UDI-Device Identifier: 07613336140864
• UDI-Public: 07613336140864
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Report Date (Section B): 12/09/2025

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: 12/31/2025
• Device Catalogue Number: 07475918190
• Device Lot Number: 853644
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/13/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 12/09/2025
• 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 Age: 15 YR
• Patient Sex: Male