MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS B 221 4 SYSTEM; BLOOD GAS ANALYZER

Catalog Number	03337138001
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	02/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received questionable results for one patient sample tested on a cobas b 221 4 system.Results for the following parameters were questionable: pco2, po2, ph, na+, k+, ca2+, so2, be, p50.A first sample was collected from the patient was tested on the analyzer at 18:30, resulting in the following values: pco2 = 53.5 mmhg with a data flag po2 = 74.0 mmhg with a data flag ph = 7.089 with a data flag na+ = 131.5 mmol/l with a data flag k+ = "out of range" (> 20.00 mmol/l) with a data flag ca2+ = "out of range" (< 0.100 mmol/l) with a data flag so2 = 86.8 % with a data flag be = -13.8 mmol/l p50 = 37.6 mmhg the results from the first sample showed severe respiratory acidosis based on the ph, pco2, and be results.As the results did not correlate to the clinical condition of the patient, a second sample was collected from the patient and tested on the analyzer.The second sample was tested at 18:49 and resulted in the following values: pco2 = 31.8 mmhg with a data flag po2 = 44.3 mmhg with a data flag ph = 7.396 na+ = 146.1 mmol/l with a data flag k+ = 2.92 mmol/l with a data flag ca2+ = 0.557 mmol/l with a data flag so2 = 75.9 % with a data flag be = -5.0 mmol/l p50 = 29.0 mmhg the second sample values agreed with the patient's clinical picture.
Additional Manufacturer Narrative
The electrode lot numbers and expiration dates were requested, but not provided.The investigation is ongoing.
Additional Manufacturer Narrative
The investigation determined the instrument performed as designed, and there was no indication of a malfunction.Qc for all relevant tests was acceptable.Calibrations were acceptable, and electrode signals were correct.The discrepancies in test results were not related to the instrument nor to the consumables.The investigation determined the event was consistent with preanalytical issues.

• Brand Name: COBAS B 221 4 SYSTEM
• Common Device Name: BLOOD GAS ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE INSTRUMENT CENTER AG TEGIMENTA; forrenstrasse; rotkreuz 6343 ; WZ 6343
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18798005
• Report Number: 1823260-2024-00578
• Device Sequence Number: 20660596
• Product Code: CHL
• UDI-Device Identifier: 04015630018321
• UDI-Public: 04015630018321
• Combination Product (Y/N): Y
• Initial Reporter Country: TC
• 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): 05/08/2024

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: 03337138001
• 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: 02/09/2024
• Supplement Date Received by Manufacturer: 05/08/2024
• Initial Report FDA Received Date: 02/28/2024
• Supplement Report FDA Received Date: 05/08/2024
• 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
• Patient Age: 12 MO
• Patient Sex: Unknown