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

Catalog Number	03183700190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas integra 400 plus serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable lactate/lactate stat results from the cobas integra 400 plus compared to a mykov (kovalent) system.Sample 1 initial result was 44.49 mg/dl, and the mykov result was 6.1 mg/dl.Sample 2 initial result was 109.47 mg/dl, and the mykov result was 70.9 mg/dl.Sample 3 initial result was 41.7 mg/dl, and the mykov result was 23.7 mg/dl.The results from the integra were not released outside of the lab as they were deemed to be incorrect and did not match the patient's clinical status.
Additional Manufacturer Narrative
Qc and calibration did not show any issues.The investigation was unable to determine a direct root cause.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21641469
• Report Number: 1823260-2025-00779
• Device Sequence Number: 20736636
• Product Code: KHP
• UDI-Device Identifier: 04015630918911
• UDI-Public: 04015630918911
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2025

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: 05/31/2025
• Device Catalogue Number: 03183700190
• Device Lot Number: 803020
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2025
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 05/13/2025
• 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