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

Catalog Number 03337154001

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/08/2022

Event Type  malfunction  

Manufacturer Narrative

There were no issues with other patient samples that were tested on the b 221 analyzer before or after this particular patient sample.The customer cross-checked other patient samples tested on the b 221 analyzer with the laboratory and the results were consistent with one another.The cuvette was replaced and calibration was repeated.The field service engineer (fse) did not identify any instrument issues.The investigation is ongoing.

Event Description

The initial reporter questioned a low result for 1 patient tested for the total hemoglobin (thb) parameter on a cobas b 221 6 roche omni s6 system.The initial result from the b 221 analyzer was 53.4 g/l.A new sample was obtained and tested in the laboratory with a result of 73 g/l."later on" the thb result was 80 g/l.The date and time of this result were not provided.It is not clear if this result was from the original sample or a new sample.It is not clear if this result was from the laboratory or the b 221 analyzer.The questionable low result was reported outside of the laboratory.The thb cassette lot number and expiration date were not provided.

Manufacturer Narrative

The investigation reviewed sample-related data, qc data, calibrations, and fluidics/optical data.Qc results were within specification for the thb parameter.Calibrations were acceptable.The alleged result of 80 g/l was not identified within the data provided.Only the result of 53.4 g/l was observed within the data provided.The patient also had lower than normal results for other parameters that were measured (po2, pco2, k, and ca).The patient had an hct of 22.9%; the b 221 instrument flagged this for checking.The flag that was displayed indicates the hct result was low compared to normal ranges.Blood residuum values were reviewed and there was no indication of any interfering substances or any measurement anomalies.Other fluidics/optical data were reviewed showing no evidence of an instrument issue.From the data available, the investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: COBAS B 221 <6> SYSTEM
• Type of Device: BLOOD GAS ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15960081
• MDR Text Key: 307891098
• Report Number: 1823260-2022-03973
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 04015630018345
• UDI-Public: 04015630018345
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K032311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03337154001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1