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

Catalog Number 05122287001

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi)#: (b)(4).

Event Description

The customer states they have questionable high sodium results on the cobas b 123 <4> system (b123).When results are compared to the laboratory, they are higher on the b123 analyzer.The customer performed a sample comparison with a second b123 analyzer and the results were 137 mmol/l and 138 mmol/l compared to results of 142 mmol/l and 143 mmol/l with the complained analyzer.The customer stated they had 2 reports of results from the complained b123 analyzer being 10 mmol/l different from the laboratory result.The customer provided data for one patient sample which had an erroneous result.When tested on the complained b123 analyzer, a sample resulted as 130 mmol/l which was reported outside of the laboratory.The patient was then transferred based on the result.A sample from the patient was then tested in the laboratory, resulting as 140 mmol/l.No adverse events were alleged.Quality controls run on the complained b123 analyzer were ok and all calibrations were ok.The customer ran a comparison of 5 patient samples with a separate analyzer and found a bias of 4 mmol/l with the complained b123 analyzer.The customer then had the laboratory staff run the same check between the two instruments and found the same bias.There was no bias seen with controls.The field service engineer ran simulator checks and these all passed.He checked correlation factors installed in the analyzer software and these were correct.The factors matched those entered in a nearby analyzer.

Manufacturer Narrative

The field service engineer performed service checks on the analyzer.All checks were okay.He ran controls and checked all sample modes.He ran several comparison tests for sodium with other b123 analyzers over a period of 9 days.He found no discrepancies when comparing to other analyzers.

Manufacturer Narrative

Request from fda: could you clarify what the "standby drift" means and what was the cause for it? response from manufacturer: standby solution is an internal calibrator of the cobas b 123.The voltage of the standby solution is measured after the blood sample for the measurement value calculation.The standby drift means the voltage of the standby solution drifted from its nominal value.This may be caused by an interference from a specific blood sample.Request from fda: also, how was the issue addressed in the new version of the software issued in september? response from manufacturer: in the new version of software, the standby drift is monitored.In case the standby drift is over the defined threshold, the drift will be corrected in order to obtain correct measurement result.Request from fda: were the customers notified that there was such a drift with the previous version of the software? response from manufacturer: us customers were not notified as there are no active b123 analyzers in the united states.The analyzer is also not manufactured in the united states.Globally, impacted customers are required to be notified of the issue.

Manufacturer Narrative

This issue was caused by a high standby drift after a sample was run.This is a known issue addressed in a new software version issued in september 2018.Retention testing on lot # 21580091 of the na sensor, the lot involved in the event, was acceptable.

Manufacturer Narrative

In reference to the values from one patient that were initially reported as 130 mmol/l from the b123 analyzer and 140 mmol/l from the laboratory, updated data has been provided.It was asked, but it is not known if this updated data is from the same patient sample originally reported or if it was from a different patient sample.New data was provided for the patient as follows: on (b)(6) 2018 at 01:49, the patient had a b123 sodium result of 135 mmol/l.On (b)(6) 2018 at 02:00, the patient had a laboratory sodium result of 126 mmol/l.The customer ran an additional comparison using pooled patient blood, comparing results between the complained b123 analyzer and a second b123 analyzer.This showed a 4 mmol/l lower bias in results of the complained b123 analyzer.The field service engineer stated that there are new consumables installed on the complained b123 analyzer.He stated that all levels of control are passing and compare very well to values measured on a second b123 analyzer.He stated that the customer has installed correlation factors in the system software for the sodium, calcium, and chloride parameters on the complained b123 analyzer.The engineer installed the same factors on the second b123 analyzer that was used for comparison.

• Brand Name: COBAS B 123 <4> SYSTEM
• Type of Device: BLOOD GAS ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7590631
• MDR Text Key: 111441735
• Report Number: 1823260-2018-01852
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• PMA/PMN Number: K111188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05122287001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1