MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ALANINE AMINOTRANSFERASE ACC. TO IFCC W/ PYRIDOXAL PHOSPHATE ACTIVATION; ALT/SGPT TEST

Catalog Number	08056773190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas pure c 303 analytical unit serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable aspartate aminotransferase (ast) and alanine aminotransferase (alt) results for one patient from the cobas pure c 303 analytical unit.The customer alleged something with the patient sample caused different results for the assays with pyridoxal phosphate activation compared to the assays without as were used on the cobas c311.This medwatch will cover alt.Refer to the medwatch with a1 patient identifier (b)(6) for the ast assay.For alt: the initial results were 44.1 u/l and 42.3 u/l.The repeat results using cobas c311 analyzers were 15 u/l, 19.4 u/l, and 19 u/l.The results from the cobas c311 were believed correct and reported outside of the laboratory.
Additional Manufacturer Narrative
The investigation found in this case, two different assay types were used to determine the alt and ast, one assay with activation and one without activation.The patient was suspected to have a liver tumor/liver disease.Liver diseases can be associated with plp deficiency and increased transaminase results, which are not properly detected with non-activating tests.A lack of plp (pyridoxalphospha) can lead to false low alt and ast results with the nonactivated assays.The calibration and qc for each assay were acceptable.A hardware check test was performed on the analyzer and was acceptable.The investigation did not identify a product problem.

• Brand Name: ALANINE AMINOTRANSFERASE ACC. TO IFCC W/ PYRIDOXAL PHOSPHATE ACTIVATION
• Common Device Name: ALT/SGPT TEST
• 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: 21127329
• Report Number: 1823260-2025-00092
• Device Sequence Number: 7465002
• Product Code: CKA
• UDI-Device Identifier: 07613336120989
• UDI-Public: 07613336120989
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• PMA/510(K) Number: K954992
• 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): 02/25/2025

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: 08056773190
• Device Lot Number: 79945301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/23/2024
• Supplement Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 02/25/2025
• 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