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	04/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a questionable alanine aminotransferase acc.To ifcc without pyridoxal phosphate activation result from the cobas 6000 c501 module, suspecting a negative interference.The initial result was 67.3 u/l, accompanied by a data flag, with a repeat result of 97.6 u/l, also accompanied by a data flag.After the sample was diluted, the data flag did not occur, however, this result was not reproducible on repeat testing on different analyzers.
Additional Manufacturer Narrative
The cobas 6000 c501 module serial number is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
A general reagent issue is unlikely because qc and calibration were in range at the time of the event.The investigation was unable to determine an exact root cause, and no product issue was found.

• 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
• MDR Report Key: 22116026
• Report Number: 1823260-2025-01674
• Device Sequence Number: 7176207
• Product Code: CKA
• UDI-Device Identifier: 04015630913862
• UDI-Public: 04015630913862
• Combination Product (Y/N): N
• Initial Reporter Country: MT
• 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): 07/08/2025

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 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): Initial
• Initial Date Received by Manufacturer: 05/07/2025
• Supplement Date Received by Manufacturer: 07/04/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 07/08/2025
• 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: ENTACAPONE; LEVODOPA; ORAL CO-CARBIDOPA; ORAL LEVOTHYROXINE 50 MCG O.D; SUBCUTANEOUS LOW-MOLECULAR WEIGHT HEPARIN
• Patient Age: 81 YR
• Patient Sex: Male