MAUDE Adverse Event Report: ROCHE DIAGNOSTICS LACTATE/LACTATE STAT; LACTIC ACID TEST SYSTEM

Catalog Number	03183700190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the analyzer was (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of a questionable lactate/lactate stat assay result for a patient sample tested on a cobas 6000 c (501) module.The initial result was 0.25 mmol/l.The repeat result was 2.54 mmol/l.The repeat result was deemed correct.
Additional Manufacturer Narrative
The customer reported that their qc was passing before the event, and was not rerun when the problem occurred.A review of the alarm trace data revealed abnormal probe sucking and sample short errors.These are indicators of possible poor sample quality.The field service engineer (fse) confirmed the problem was due to using an incorrect method for updating the water calibrator.The fse rebuilt the water calibrator and verified the instrument by recalibrating all affected applications, rerunning qc, and repeating patient samples.The investigation determined that the service actions resolved the issue.

• Brand Name: LACTATE/LACTATE STAT
• Common Device Name: LACTIC ACID TEST SYSTEM
• 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: 23728711
• Report Number: 1823260-2025-04961
• Device Sequence Number: 18409995
• Product Code: KHP
• UDI-Device Identifier: 04015630918911
• UDI-Public: 04015630918911
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 12/18/2025

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 Catalogue Number: 03183700190
• Device Lot Number: 869915
• 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: 11/15/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 12/05/2025
• 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
• Patient Sex: Unknown