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

Catalog Number	05850819190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable results from the cobas 8000 c702 module.The customer suspected interference, as the sample in question was collected 17 hours after the patient had received red blood cells due to being anemic.The initial ast (aspartate aminotransferase) result was 17.6 u/l with an analyzer alarm.The initial alt (alanine aminotransferase) result was 11.3 u/l with an analyzer alarm.Due to the alarm, a 1:10 auto dilution was performed.The result for ast was 2.2 u/l, and the result for alt was 10.3 u/l.A new sample was collected from the patient on (b)(6) 2025, and the ast and alt results had no flags.No specific data was provided.This medwatch is for ast (aspartate aminotransferase).Refer to the medwatch with a1 patient identifier (b)(6) for the alt (alanine aminotransferase) assay.
Additional Manufacturer Narrative
The cobas 8000 c702 module serial number was (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
On (b)(6) 2025, further testing of the sample generated the following results: alt 6.8 u/l with a data flag and 7.8 u/l with a data flag.Ast 16.7 u/l with a data flag and 12.9 u/l.The investigation is ongoing.
Additional Manufacturer Narrative
Medwatch fields d4 catalog no and primary udi number, and g4 pma / 510k (premarket numbers) were updated.
Additional Manufacturer Narrative
Based on the information provided, the investigation determined that the event was consistent with the sample containing a substance that strongly absorbs at 340 nm, the measuring wavelength of the assay.The event was 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 23618537
• Report Number: 1823260-2025-04768
• Device Sequence Number: 9072612
• Product Code: CIT
• UDI-Device Identifier: 04015630928934
• UDI-Public: 04015630928934
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K951595
• 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,Followup,Followup
• Report Date (Section B): 04/28/2026

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: 05850819190
• Device Lot Number: ASKU
• 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: 10/31/2025
• Supplement Date Received by Manufacturer: 12/19/2025; 01/26/2026; 04/08/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 01/13/2026; 02/18/2026; 04/28/2026
• 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