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

Catalog Number	03337154001
Medical Device Problem Codes	Unable to Obtain Readings (1516); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable po2 and glucose results from three patient samples tested on the cobas b 221 6 roche omni s6 system.On (b)(6) 2024: patient sample 1 at 6:27 am, the initial po2 result was 96.3 mmhg.At 6:30 am, the repeat result was 124.0 mmhg.At 6:27 am, the initial glucose result was 25.0 mg/dl.At 6:30 am, the repeat result was 148.0 mg/dl.Patient sample 2 at 6:35 am, the initial po2 result was 99.2 mmhg.At 6:38 am, the repeat result was 112.1 mmhg.At 6:35 am, the initial glucose result was 17.5 mg/dl (18 mg/dl).At 6:38 am, the repeat result was 129.0 mg/dl.On (b)(6) 2024: patient sample 3 at 6:13 am, the initial glucose result was 44.4 mg/dl.At 6:19 am, the repeat result was 117.7 mg/dl.
Additional Manufacturer Narrative
The glucose cassette lot number used after the 19-jun-2024 event is 4149.The expiration date was requested but not provided.The po2 electrode lot number is 207887/30748.The expiration date was requested but not provided.The field service engineer (fse) inspected the device and determined reference contact in the metabolite-sensitive sensor (mss) needed to be replaced.The investigation is ongoing.
Additional Manufacturer Narrative
The investigation reviewed the analyzer's log files (b)(6) 2024): 117 out of 118 po2 calibrations were within specifications.573 out of 610 glucose calibrations were within specifications.The po2 qc was out of range (2x on (b)(6) 2024) but the rerun was acceptable.The glucose qc was acceptable.There were no system errors noted.The log files for patient sample 3's initial result showed a declining sample curve, while the repeat result had none.This is consistent with a pre-analytic issue (undetected interference or air bubbles in the measuring chamber).Pre-analytics are the customer's responsibility.The investigation reviewed the results of patient samples 1 and 2; it was noted that the po2 and glucose results increased, while the pco2 results decreased between the measurements.The results are consistent with metabolization due to improper storage.Based on the information provided, 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 19730847
• Report Number: 1823260-2024-02009
• Device Sequence Number: 15505561
• Product Code: CHL
• UDI-Device Identifier: 04015630018345
• UDI-Public: 04015630018345
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• 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): 10/31/2024

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): Initial
• Initial Date Received by Manufacturer: 06/20/2024
• Supplement Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 10/31/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PLEASE REFER TO THE ATTACHMENT PT-0069836.
• Patient Age: 78 YR
• Patient Sex: Male