MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ALTP GEN.2; ALT/SGPT

Catalog Number	08104697190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable altp gen.2 (alt) and aspartate amino transferase (ast) results for 1 patient sample on a cobas c 303 analytical unit.The initial alt and ast results produced data flags.It was reported that the repeated results confirmed the issue was "sample specific".An interference between the assays and the patient sample was suspected.The numerical results were not provided.This medwatch will apply to the altp gen.2 assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the aspartate amino transferase assay.
Additional Manufacturer Narrative
Due to the lack of information provided, the investigation was unable to identify a specific cause for the event.The investigation did not identify a product problem.

• Brand Name: ALTP GEN.2
• Common Device Name: ALT/SGPT
• 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: 21949333
• Report Number: 1823260-2025-01361
• Device Sequence Number: 8534986
• Product Code: CKA
• UDI-Device Identifier: 07613336130513
• UDI-Public: 07613336130513
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K801119
• 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): 06/26/2025

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: 10/31/2025
• Device Catalogue Number: 08104697190
• Device Lot Number: 83885601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 06/26/2025
• 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