MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ALANINE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION; NADH OXIDATION/NAD REDUCTION, ALT/SGPT

Catalog Number	20764957322
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c 311 analyzer serial number is (b)(6).The cobas pure analyzer serial number was not provided.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable alanine aminotransferase acc.To ifcc without pyridoxal phosphate activation (alt) results for 2 patient samples on a cobas 4000 c311 stand alone system and a cobas pure analyzer.On 21-oct-2025, sample 1 had an initial alt result of 52 iu/l from the cobas pure analyzer.The sample was also tested on a c 311 analyzer and the result was 24 iu/l.The exact date of testing on the c 311 analyzer was not provided.Sample 2 had an initial alt result of 51.2 iu/l from the cobas pure analyzer.The sample was also tested on a c 311 analyzer and the result was 21.8 iu/l.The exact dates of testing were not provided.
Additional Manufacturer Narrative
No further information was provided.The investigation did not identify a product problem.The root cause of the event could not be determined.

• Brand Name: ALANINE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION
• Common Device Name: NADH OXIDATION/NAD REDUCTION, 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 46250-0457
• MDR Report Key: 23744730
• Report Number: 1823260-2025-04992
• Device Sequence Number: 18245985
• Product Code: CKA
• UDI-Device Identifier: 04015630913862
• UDI-Public: 04015630913862
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• 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
• Report Date (Section B): 01/28/2026

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: 20764957322
• 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: 11/15/2025
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 01/28/2026
• 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