MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE OMNI S; BLOOD GAS ANALYZER

Catalog Number 03337154001

Device Problem Computer Software Problem (1112)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated they had issues with the quality control features of the cobas b 221 analyzer software.On (b)(6) 2020, a quality control was tested on the analyzer resulting with a po2 value of 10.02 kpa.The acceptable range for this control is 6.67 - 9.87 kpa.The report in the system showed a failure warning for the 10.02 kpa value.The reporter stated they also received a control failure warning for po2 on (b)(6) 2020.The reporter stated they had set the analyzer to lock the system from running patient samples if the controls failed for the po2 parameter.After the control warnings received on both dates, the system did not lock po2 testing after controls failed.The reporter noted they deactivated the po2 parameter from their cobas infinity laboratory information system on (b)(6) 2020 and had issues re-activating this parameter in the cobas infinity system.

Manufacturer Narrative

The investigation determined the instrument is working as designed.Based on the provided database files it can be confirmed that on (b)(6) 2020 a level of po2 control was out of range and thus a warning was displayed.If qc measurements for a parameter fall outside its target value range, a qc warning or qc lock is applied to the parameter.The instrument does not log a setting change.It is only possible to see when the change has happened based on the data showing a qc lock on one day and a warning on the other day.Based on the provided qc data, the warning level for po2 was already set on the (b)(6)2020.The performed qc measurements on (b)(6) 2020 were in range for po2.The provided log files cover the time frame beginning on (b)(6)2019; the first performed qc measurement was run on (b)(6)2019 at 08:34 and passed for po2.All the following qc measurements passed for po2 for all levels until the (b)(6) 2020.It is unknown when the last qc failed for po2 and showed the qc lock.The qc settings are not changed by the system, however these can be changed by an authorized person.This can also occur by accident being in the qc settings.The issue has happened before the (b)(6) 2020, however it is unknown when the qc settings for the po2 parameter were changed from qc lock to qc warning.

• Brand Name: ROCHE OMNI S
• Type of Device: BLOOD GAS ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9871736
• MDR Text Key: 221477349
• Report Number: 1823260-2020-00825
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• PMA/PMN Number: K032311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2020
• 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
• Date Manufacturer Received: 02/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1