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

Catalog Number	03337154001
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	10/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable glucose results for an unspecified number of patient samples on a cobas b 221 and system.It was alleged that the customer experienced very high blood glucose levels with this instrument compared to other devices.It was reported that samples with blood glucose levels above 100 mg/dl had a difference of 50 mg/dl when repeated, and samples with blood glucose levels above 200 mg/dl had a difference of 100 mg/dl or more when repeated.Two examples were provided.Sample 1: the initial result was 354 mg/dl.The sample was repeated on another cobas b 221 device, and the result was approximately 254 mg/dl (100 mg/dl less).The sample was repeated using "a chemistry device," and the result was "nearly the same".The type of device and the numerical result were not provided.Sample 2: the initial result was 41.8 mg/dl.The sample was repeated on another cobas b 221 device, and the results were 145 mg/dl and 146 mg/dl.The samples were repeated because the initial results were questioned by the physician.
Additional Manufacturer Narrative
The reagent lot number and expiration date were not provided.The investigation is ongoing.
Additional Manufacturer Narrative
The field service representative inspected the instrument and found that the settings for the glucose parameter had been altered from the factory defaults.Specifically, a factor was applied to the slope.The settings were corrected to the factory default values, which resolved the issue.The investigation determined that the root cause was due to a misconfiguration of the instrument settings.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: 23416585
• Report Number: 1823260-2025-04406
• Device Sequence Number: 10432282
• Product Code: CGA
• UDI-Device Identifier: 04015630018345
• UDI-Public: 04015630018345
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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): 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: 10/03/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 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 Sex: Unknown