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

Model Number	ACTH
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation did not identify a product problem.The cause of the event could not be determined.As this was considered an isolated instance of non-reproducible results, a general reagent problem could be excluded.
Event or Problem Description
There was an allegation of questionable acth elecsys e2g results from a cobas e 801 module.The serial number was requested but was not provided.The sample from (b)(6) 2022 was sent for investigation and tested on a cobas e 801 module and a cobas e 602 module.Refer to the attachment to the medwatch for patient data.The questionable results were reported outside of the laboratory to the physician.The customer believed the results from (b)(6) 2021 and (b)(6) 2022 were incorrect but believed the results from (b)(6) 2022 were correct.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15094293
• Report Number: 1823260-2022-02180
• Device Sequence Number: 5213257
• Product Code: CKG
• UDI-Device Identifier: 04015630939893
• UDI-Public: 04015630939893
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K060585
• 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
• Report Date (Section B): 07/25/2022

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 Model Number: ACTH
• 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): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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