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

Catalog Number	08104697190
Medical Device Problem Codes	Unable to Obtain Readings (1516); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas c 503 analytical unit serial number was (b)(6).The field service engineer performed a hardware test and precision, which were acceptable.The analyzer alarm trace contained numerous alarms related to sample quality.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable aspartate amino transferase and altp gen.2 results for one patient from the cobas c 503 analytical unit.The customer suspected that an interference from the patient¿s medication was causing incorrect results and data flags.The medwatch is for the altp gen.2 assay.Refer to the medwatch with a1-patient identifier (b)(6) for the aspartate amino transferase assay.The initial results had ">kin3" data flags.After the initial results, the customer retested the sample with various dilutions.The customer could not provide specific data but stated all of the results were accompanied by the data flag.The customer retested the patient sample as if it were qc material.The alt result was -7.35 u/l with a data flag.The ast result was 4.07 u/l with a data flag.A new sample was collected from the patient, and the results were the same, with the data flag.No specific data was provided.
Additional Manufacturer Narrative
The investigation determined the issue was due to pre-analytical handling issues at the customer site.Correct pre-analytic sample handling is within the customer's responsibility.There is no evidence to suggest a malfunction of the device.

• 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: 23281565
• Report Number: 1823260-2025-04172
• Device Sequence Number: 12975251
• Product Code: CKA
• UDI-Device Identifier: 07613336130513
• UDI-Public: 07613336130513
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 12/18/2025

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: 05/31/2026
• Device Catalogue Number: 08104697190
• Device Lot Number: 88078201
• 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: 09/22/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/18/2025
• 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: PHENYTOIN.
• Patient Age: 56 YR
• Patient Sex: Female