MAUDE Adverse Event Report: ROCHE DIAGNOSTICS BICARBONATE LIQUID; ENZYMATIC, CARBON-DIOXIDE

Catalog Number	03289923190
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the c501 analyzer is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received questionable results for two samples collected from the same patient and tested with bicarbonate liquid on a cobas 6000 c501 module.It is alleged that the patient's samples contain an interfering factor against a component of the bicarbonate assay.The first sample from the patient resulted in bicarbonate values of 7.1 mmol/l and 7.1 mmol/l.A re-collection of the patient was requested.A second sample (plasma) was collected from the patient and tested on (b)(6) 2025, resulting in bicarbonate values of 2.9 mmol/l and 2.3 mmol/l.This same plasma sample was repeated on an unknown blood gas analyzer, resulting in a bicarbonate value of 22.6 mmol/l.The whole blood tube from the same collection was also tested on the blood gas analyzer, resulting in a bicarbonate value of 24.4 mmol/l.
Additional Manufacturer Narrative
For the second sample collected from the patient, the specific raw data values from the blood gas analyzer are as follows: plasma tube results: pco2 32.4 mmhg, ctco2 (b) = 19.11 mmol/l, ctco2 (p) = 23.2 mmol/l.Whole blood tube results: pco2 47.8 mmhg, ctco2 (b) = 24.40 mmol/l, ctco2 (p) = 29.0 mmol/l.
Additional Manufacturer Narrative
Quality controls were acceptable.There was no indication of a reagent performance issue.The investigation could not identify a product problem.The cause of the event could not be determined.The issue is most consistent with a sample specific issue related to sample quality.

• Brand Name: BICARBONATE LIQUID
• Common Device Name: ENZYMATIC, CARBON-DIOXIDE
• 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 46250-0457
• MDR Report Key: 22955113
• Report Number: 1823260-2025-02715
• Device Sequence Number: 21211133
• Product Code: KHS
• UDI-Device Identifier: 04015630919352
• UDI-Public: 04015630919352
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K031879
• 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,Followup
• Report Date (Section B): 12/30/2025

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: 03289923190
• Device Lot Number: ASKU
• 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: 08/14/2025
• Supplement Date Received by Manufacturer: 09/03/2025; 12/23/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 09/26/2025; 12/30/2025
• 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