MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ALANINE AMINOTRANSFERASE ACC. TO IFCC; NADH OXIDATION/NAD REDUCTION, ALT/SGPT

Catalog Number	05850797190
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 8000 cobas c 701 module serial number was (b)(6).The ast reagent used on the cobas pro c503 analyzer was expired at the time of the sample testing.The investigation did not identify a product problem.The cause of the event could not be determined.
Event or Problem Description
There was an allegation of questionable alanine aminotransferase acc.To ifcc (alt) results from the cobas 8000 cobas c 701 module.The customer suspected an interference.The initial result was 0.2 u/l.The repeat result with a decreased sample volume was -3.7 u/l with a data flag.The repeat result with an increased sample volume was 1.4 u/l.The result using the j&j (dry chemical test) method was 43.8 u/l.The customer tested the sample using the altp gen.2 reagent on a cobas pro c503 analyzer and the result was 71.8 u/l the questionable results were not reported outside of the laboratory.

• Brand Name: ALANINE AMINOTRANSFERASE ACC. TO IFCC
• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21752473
• Report Number: 1823260-2025-00984
• Device Sequence Number: 9658610
• Product Code: CKA
• UDI-Device Identifier: 04015630928927
• UDI-Public: 04015630928927
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 04/02/2025

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: 05850797190
• Device Lot Number: 81382001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 04/02/2025
• 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: ADENOSYLEMETHIONINE DISULFONATE.; CELECOXIB CAPSULES.; HEPARIN SODIUM INJECTION.; HUMAN ALBUMIN INJECTION.; IMIPENEM-CILASTATIN FOR INJECTION.; LIDOCAINE INJECTION.; MAGNESIUM ISOGLYCYRRHIZINATE INJECTION.; MORPHINE HYDROCHLORIDE INJECTION.; NOREPINEPHRINE BITARTRATE INJECTION.; ORNITHINE ASPARTATE INJECTION.; POLYENE PHOSPHATIDYLCHOLINE.; PROMETHAZINE HYDROCHLORIDE INJECTION.
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian