MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS B 123 <4> SYSTEM; BLOOD GAS ANALYZER

Catalog Number	05122279001
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred in (b)(6).
Event or Problem Description
The customer complained of discrepant results for 1 patient tested for hemoglobin and hct on a cobas b 123 instrument compared to the beckman coulter hematology analyzer.The patient was initially tested on the b 123 instrument with a hemoglobin result of 4.1 g/dl and an hct of 16%.These results were reported outside of the laboratory where the physician treated the patient with a transfusion of 2 units of erythrocyte concentrates.The patient was tested by the beckman coulter analyzer and the hemoglobin result was 8.2 g/dl and the hct was 24.9% so the transfusion was not necessary.There was no allegation that an adverse event occurred due to the transfusion.The sensor cartridge lot number and expiration date were not provided.Qc values for hemoglobin were acceptable.No alarms were produced by the b 123 instrument.
Additional Manufacturer Narrative
The customer indicated that the transfusion was performed on the same day as the erroneous results were obtained (b)(6) 2018) in the afternoon (exact time not indicated).The provided printout of comparison results from cobas b 123 sn (b)(4)is dated from (b)(6)2018 at 00:48; and the printout of measurement performed on the beckman coulter is dated from (b)(6) 2018 at 01:43.Further clarification regarding the dates of the measurements were requested, but not provided.Hemoglobin and hct are measured independently from each other on the b 123 system.Both results are decreased in comparison to the coulter results.The results obtained are consistent with a preanalytical sample handling problem, such as sedimentation in a poorly mixed whole blood sample.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: COBAS B 123 <4> SYSTEM
• Common Device Name: BLOOD GAS ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7946657
• Report Number: 1823260-2018-03487
• Device Sequence Number: 16708209
• Product Code: CHL
• UDI-Device Identifier: 04015630036943
• UDI-Public: 4015630036943
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K111188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2019

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: 05122279001
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/20/2018
• Supplement Date Received by Manufacturer: 09/20/2018
• Initial Report FDA Received Date: 10/09/2018
• Supplement Report FDA Received Date: 01/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR