MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ACTH; ADRENOCORTICOTROPIC HORMONE (ACTH) TEST SYSTEM

Catalog Number	07026684190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable high results for 1 patient tested for elecsys acth (acth) on a cobas e 801 analytical unit.The acth results are allegedly high with no known cause, as the patient is asymptomatic (previously cushing's disease).The initial result was 118,000 pg/ml.The sample was repeated with various dilutions: x5: > 2000 pg/ml with a data flag, x10: >2000 pg/ml with a data flag, x20: >2000 pg/ml with a data flag, x40: >2000 pg/ml with a data flag, x75: 118,350 pg/ml, x100: 126,400 pg/ml.On (b)(6) 2025, a new sample was obtained, and the result was approximately 25,000 pg/ml.
Additional Manufacturer Narrative
The e801 analyzer serial number was (b)(6).Sample material from the patient was received for investigation.The customer's high acth results were reproduced at the investigation site.Sample material from the patient was sent to an external laboratory and tested by the siemens method, where the acth was also extremely high (80,163 pg/ml).Interference testing using size exclusion chromatography (sec) was performed.No interference was found.Peptide mapping analysis of the sample fractions suggests the high elecsys acth results are consistent with an erroneous detection of a different peptide from the higher-level proopiomelanocortin (pomc) protein.

• Brand Name: ELECSYS ACTH
• Common Device Name: ADRENOCORTICOTROPIC HORMONE (ACTH) TEST SYSTEM
• 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: 23905893
• Report Number: 1823260-2025-05351
• Device Sequence Number: 18633028
• Product Code: CKG
• UDI-Device Identifier: 04015630939893
• UDI-Public: 04015630939893
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K060585
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/29/2025

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 Catalogue Number: 07026684190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 12/29/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DETA; ESCITALOPRAM; ESTRADIOL; FISH OIL; FLUDROCORTIZONE; HYDROCORTISONE; PREDNISONE; PROBIOTICS; PSYLLIUM; SOLU-CORTEF; SOMATROPIN INJECTION; VITAMIN C
• Patient Age: 65 YR
• Patient Sex: Female