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

Catalog Number	03004732122
Medical Device Problem Codes	Incorrect Measurement (1383); Low Test Results (2458); Insufficient Device Problem Information (3190); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The field service engineer (fse) checked all analyzer parts, function of the analyzer, rinse water vacuum and pressure, and performed a precision test successfully.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable lactate dehydrogenase results for 1 patient sample on a cobas 8000 cobas c 502 module.The initial result was 154 u/l.The doctor questioned the result which prompted the customer to repeat the sample.The sample was repeated on another c502 analyzer and the result was 310 u/l.The repeat result was deemed correct.
Additional Manufacturer Narrative
Calibration was last performed on (b)(6) 2025 and was within specification.The customer stated verbally that their qc was within specification.The alarm trace showed an abnormal aspiration error.This is an indicator of possible poor sample quality.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: 23556581
• Report Number: 1823260-2025-04649
• Device Sequence Number: 18599147
• Product Code: CFJ
• UDI-Device Identifier: 04015630916276
• UDI-Public: 04015630916276
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 12/16/2025

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: 04/30/2026
• Device Catalogue Number: 03004732122
• Device Lot Number: 87334701
• 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: 10/23/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 12/16/2025
• 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