MAUDE Adverse Event Report: ROCHE DIAGNOSTICS LACTATE DEHYDROGENASE; LACTATE DEHYDROGENASE ASSAY USING NAD/NADH

Catalog Number	03004732122
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable lactate dehydrogenase (ldh) results for 2 patient samples on a cobas 8000 cobas c 502 module.This medwatch will cover ldh.Refer to medwatch with a1 patient identifier (b)(6) for information on the alp results, medwatch with a1 patient identifier (b)(6) for information on the calcium results, medwatch with a1 patient identifier (b)(6) for information on the lactate results, and medwatch with a1 patient identifier (b)(6) for information on the ast results.The doctor questioned the results as they were high and did not match the clinical status of outpatients in "normal" condition.No specific sample results were provided.
Additional Manufacturer Narrative
The calibration recovery data provided was within specification.The qc recovery data for the affected assays was high but within the customer's established ranges.The field service engineer (fse) evaluated the analyzer.New roche qc was ordered and performed by the customer with adjusted means.Qc was performed within specification.The investigation did not identify a product problem.The root cause of the event could not be determined.

• Brand Name: LACTATE DEHYDROGENASE
• Common Device Name: LACTATE DEHYDROGENASE ASSAY USING NAD/NADH
• 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: 23657157
• Report Number: 1823260-2025-04866
• Device Sequence Number: 11968276
• Product Code: CFJ
• UDI-Device Identifier: 04015630916276
• UDI-Public: 04015630916276
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K964457
• 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): 02/02/2026

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 Expiration Date: 09/30/2026
• Device Catalogue Number: 03004732122
• Device Lot Number: 88236001
• 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: 11/05/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 02/02/2026
• 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