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

Catalog Number 03337154001

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/13/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer stated that they obtained results for one patient sample using the cobas b 221<6>=roche omni s6 system (b221) (sample id (b)(6)).The results were sent from the b221 analyzer to the cobas infinity system database.The customer then analyzed a different patient sample (sample id (b)(6)).They noticed that the results in the database corresponded to the previous sample, and did not match the results provided by the analyzer.Information was provided that the results were validated and released outside of the laboratory.The customer stated that the issue happens when the sample id is equal to the patient id of the last sample processed.When this occurs, the b221 analyzer appears to change the sample id.The customer has had to manually edit results in the infinity database system due to the issue.There was no allegation that an adverse event occurred.Further information was requested for investigation, and investigation activities are ongoing.

Manufacturer Narrative

The investigation could reproduce the customer's observation.Based on the provided information, the customer changed the patient id to the id for the second patient while the first sample was still running on the analyzer.This action lead to the mismatch in the cobas infinity system database.The software performed as intended - the customer can change the patient id while a sample is running.It was recommended for the customer to wait until the instrument completes processing of a sample and goes back to the ready screen before entering the next sample id.The printed reports for both patient samples were correct.The instrument software met specifications.

• Brand Name: ROCHE OMNI S
• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6672809
• MDR Text Key: 78609363
• Report Number: 1823260-2017-01356
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: K032311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• 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: 06/13/2017
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1