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

Catalog Number	08104719190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the c 503 analyzer is (b)(6).Upon review of the analyzer reaction data, anormal reactions were observed for all measurements except the 3934 u/l measurement.Flags indicating a reaction issue mean either the sample concentration is too high, the sample turbidity is too high, or the reagent is deteriorated.Calibration data was acceptable.Medwatch field e1.Initial reporter establishment name: (b)(6).The investigation is ongoing.
Event or Problem Description
Roche diagnostics received a customer complaint regarding alleged non-reproducible astp2 assay results for one patient sample tested on a cobas c 503 analytical unit.The sample initially resulted in an ast value of 19.4 u/l.The sample was repeated, but it resulted in no value, only a flag indicating a reaction issue.The sample was diluted 1:20 and repeated, resulting in an ast value of 3934 u/l.The sample was repeated two additional times on (b)(6) 2025, but each time it did not result in a value, only a flag indicating a reaction issue.
Additional Manufacturer Narrative
The investigation determined the issue is consistent with a sample specific issue.The investigation could not identify a product problem.

• 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: 21865197
• Report Number: 1823260-2025-01180
• Device Sequence Number: 12734703
• Product Code: CIT
• UDI-Device Identifier: 07613336130537
• UDI-Public: 07613336130537
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 04/30/2025

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): Initial
• Initial Date Received by Manufacturer: 03/28/2025
• Supplement Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 04/30/2025
• 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: Unknown