MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ASPARTATE AMINO TRANSFERASE; NADH OXIDATION/NAD REDUCTION, AST/SGOT

Catalog Number	08104719190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable aspartate amino transferase results from the cobas c 503 analytical unit.The initial result was 6.18 u/l.The repeat result with a 1:20 dilution was 3772 u/l with a data flag.The next day the result from a new sample had a high result accompanied by a data flag.No specific data was provided.
Additional Manufacturer Narrative
Due to the limited information provided, the investigation was unable to determine a specific root cause.The investigation found the event was consistent with a sample-specific issue.There was no product problem identified.

• Brand Name: ASPARTATE AMINO TRANSFERASE
• Common Device Name: NADH OXIDATION/NAD REDUCTION, AST/SGOT
• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21741562
• Report Number: 1823260-2025-00968
• Device Sequence Number: 8790204
• Product Code: CIT
• UDI-Device Identifier: 07613336130537
• UDI-Public: 07613336130537
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 05/28/2025

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: 08104719190
• Device Lot Number: 833999
• 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: 03/11/2025
• Supplement Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 05/28/2025
• 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 Sex: Female