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	10/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable aspartate amino transferase results for 1 patient on a cobas c 503 analytical unit.The initial result was 923 u/l.The patient was suspected of having a neuromuscular pathology but without the alteration of the other rhabdomyolysis parameters.The sample was repeated on another module and the result was 145 u/l.A new sample was obtained and the result was 967 u/l.The sample was automatically repeated with a 1:10 dilution and the result was 974 u/l.Repeat testing was performed due to the initial results not matching the patient's clinical status.
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The sample was requested for investigation.The investigation is ongoing.
Additional Manufacturer Narrative
The calibration and qc were acceptable.A general reagent issue was excluded.The issue is consistent with the patient's condition (rhabdomyolysis), which can cause an increase in transaminase without an increase in liver parameters.The investigation did 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: 20633453
• Report Number: 1823260-2024-03219
• Device Sequence Number: 12620436
• 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): 01/07/2025

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: 809426
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2024
• Supplement Date Received by Manufacturer: 12/23/2024
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 01/07/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: VITAMIN D SUPPLEMENT
• Patient Sex: Unknown