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

Catalog Number	03337154001
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cartridge lot numbers and their expiration dates were not provided.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable hemoglobin (thb) and hematocrit results from fourteen (14) patient samples tested on the cobas b 221 <6> system.The following are examples of discrepant results for 4 patient samples: patient sample 1 on (b)(6) 2025, the following are the results from the analyzer: the initial thb result was 5.29 g/dl.The initial hematocrit result was 17.2%.On (b)(6) 2025, the following are the results from the flow cytometer: the repeat thb result was 7.7 g/dl.The repeat hematocrit result was 23.7%.Patient sample 2: on (b)(6) 2025, the following are the results from the analyzer: the initial thb result was 4.83 g/dl.The initial hematocrit result was 28.3%.On (b)(6) 2025, the following are the results from the flow cytometer: the repeat thb result was 6.1 g/dl.The repeat hematocrit result was 17.7%.Patient sample 3: on (b)(6) 2025: the initial hematocrit result from the analyzer was 18.6% (the thb result was 3.16 g/dl).The repeat hematocrit result from the flow cytometer was 10% (the thb result was 3.2 g/dl).Patient sample 4: the initial hematocrit result from the analyzer was 20.7% (the thb result was 5.14 g/dl).The repeat hematocrit result from the flow cytometer was 15.2% (the thb result was 4.8 g/dl).The questionable results were not reported outside of the laboratory.The reporter follows the general rule that the hematocrit should be three times the thb result, prompting the rerun of the patient samples.The flow cytometer results were deemed believable.
Additional Manufacturer Narrative
Medwatch field d2b procode updated.
Additional Manufacturer Narrative
Due to the limited information provided, the investigation was unable to determine a specific root cause.There was no product problem identified.

• 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: 22873230
• Report Number: 1823260-2025-02590
• Device Sequence Number: 10371161
• Product Code: KHG
• UDI-Device Identifier: 04015630018345
• UDI-Public: 04015630018345
• Combination Product (Y/N): N
• Initial Reporter Country: PK
• 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,Followup
• Report Date (Section B): 12/12/2025

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: 07/31/2025
• Supplement Date Received by Manufacturer: 09/02/2025; 11/25/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 10/01/2025; 12/12/2025
• 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 Age: 35 YR
• Patient Sex: Female