MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ACTH; RADIOIMMUNOASSAY, ACTH

Catalog Number	03255751190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable elecsys acth test system (acth) results from one patient sample tested on the cobas 8000 - cobas e 602 module with serial number: (b)(4).The initial results were reported to the physician who requested a rerun.The reporter stated that they believe there was an analytical interference with the result from this patient sample.The patient sample was also rerun on their other e 602 module with serial number: (b)(4), but the reporter was not able to provide the result from this module.The patient sample was also sent to another laboratory that uses a siemens analyzer.The initial result from the module using the primary tube was 102.4 pg/ml.The first repeat result from the module using the primary tube was 101.7 pg/ml.The second repeat result from the other laboratory's analyzer using an aliquot sample was 64 pg/ml.The reference range is 6-50 pg/ml.The reporter diluted the patient samples as part of their investigation.The third repeat result from the module using the patient sample in a 1:2 dilution was 111.6 pg/ml.The fourth repeat result from the module using the patient sample in a 1:4 dilution was 124.4 pg/ml.
Additional Manufacturer Narrative
The patient sample was requested for investigation.
Additional Manufacturer Narrative
The patient sample was received for investigation.The investigation was able to reproduce the customer's result.The investigation also performed a confirmatory test and confirmed the customer¿s results.Exclusion chromatography was performed and the results did not show the presence of an interfering factor.The investigation determined the customer's results were correct.The investigation did not identify a product problem.

• Brand Name: ELECSYS ACTH
• Common Device Name: RADIOIMMUNOASSAY, ACTH
• 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: 16272046
• Report Number: 1823260-2023-00286
• Device Sequence Number: 5925242
• Product Code: CKG
• UDI-Device Identifier: 04015630921522
• UDI-Public: 04015630921522
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 04/03/2023

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: 03255751190
• Device Lot Number: 606471
• 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: 01/04/2023
• Supplement Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 01/31/2023
• Supplement Report FDA Received Date: 04/03/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NORVASC 5MG; PRAVASTATIN 40MG; REMERON 30MG; SYNTHROID 50UG
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 76 KG