MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS B 221 <6> SYSTEM; BLOOD GAS ANALYZER

Catalog Number	03337154001
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cartridge lot number and the expiration date were requested but not provided.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable hemoglobin and hematocrit results from one patient sample tested on the cobas b 221 <6> system.The initial hemoglobin result from the analyzer was 4.31 g/dl (43.1 g/l).The repeat result from another laboratory device was 7.91 g/dl (79 g/l).The initial hematocrit result from the analyzer was 12.7%.The repeat result from another laboratory device was 0.23 l/l (23%).The repeat results were deemed correct.
Additional Manufacturer Narrative
The investigation noted that the initial run from the analyzer and the repeat run from the other device were performed three hours apart.The result of the investigation's computation of the mean corpuscular hemoglobin concentration (mchc) of the patient sample was acceptable.The investigation determined that the analyzer's results were correct.The investigation determined the event was consistent with a preanalytic error (sample inhomogeneity between the two patient sample runs) at the customer site.The investigation did not identify a product problem.

• Brand Name: COBAS B 221 <6> SYSTEM
• Common Device Name: BLOOD GAS ANALYZER
• 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: 22902309
• Report Number: 1823260-2025-02623
• Device Sequence Number: 15458267
• Product Code: CEM
• UDI-Device Identifier: 04015630018345
• UDI-Public: 04015630018345
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: K032311
• 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): 10/13/2025

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 Catalogue Number: 03337154001
• 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: 08/01/2025
• Supplement Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 10/15/2025
• 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