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

Catalog Number	08104697190
Medical Device Problem Codes	Signal Artifact/Noise (1036); Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas c 503 analytical unit serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable altp gen.2 results for one patient from the cobas c 503 analytical unit.The initial result was 18.5 u/l.The repeat result using a cobas 8000 analyzer was 34 u/l.The questionable result was not reported outside of the laboratory.The repeat result was believed to be correct.
Additional Manufacturer Narrative
The investigation determined the issue was due to pre-analytical handling and sample quality issues at the customer site.Correct pre-analytic sample handling is within the customer's responsibility.General reagent, calibrator, or analyzer issues were excluded.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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 23905280
• Report Number: 1823260-2025-05349
• Device Sequence Number: 9092848
• Product Code: CKA
• UDI-Device Identifier: 07613336130513
• UDI-Public: 07613336130513
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2026

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: 08104697190
• Device Lot Number: 822694
• 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: 12/11/2025
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 03/06/2026
• 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