MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITH PYRIDOXAL PHOSPHATE ACTIVATION; ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM

Catalog Number	04467493190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 4000 c311 stand alone system serial number is (b)(6).A field service engineer (fse) ran probe washes and verified the gear pump pressure was within range.The fse checked probes, washing, and rinse mechanism levels.They ran roche qc's and biorad qc's for the ast.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable astl/pyp results from the cobas 4000 c311 stand alone system.Patient 1's initial result was 12.9 u/l, and the repeat results of 20.3 u/l and 21.7 u/l with a new calibration lot on 27-mar-2025.Patient 2's initial result was 16.2 u/l, and the repeat results of 22.6 u/l and 19.5 u/l with a new calibration lot on 27-mar-2025.The result of 22.6 u/l for patient 2 was deemed to be correct.The customer discovered the questionable results during method comparison testing.
Additional Manufacturer Narrative
Section d, device identification was updated.Relevant fields of sections d and g were updated.The alarm trace did not contain any conspicuous events.The roche qc was passing before the event.The biorad qc was within range on the day of the event but out of range on (b)(6) 2025.The investigation was unable to determine a direct root cause.However, the instrument was verified, and the issue appears to be resolved.

• Brand Name: ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITH PYRIDOXAL PHOSPHATE ACTIVATION
• Common Device Name: ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM
• 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 46250-0457
• MDR Report Key: 21854485
• Report Number: 1823260-2025-01172
• Device Sequence Number: 11942236
• Product Code: CIT
• UDI-Device Identifier: 04015630920549
• UDI-Public: 04015630920549
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2025

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 Expiration Date: 07/31/2025
• Device Catalogue Number: 04467493190
• Device Lot Number: 79982801
• 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: 03/27/2025
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 05/15/2025
• 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