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 07/11/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer complained of erroneous results for 1 patient sample tested for sodium (na) on a cobas b 221 system.The initial na result was 146 mmol/l.This result was reported outside of the laboratory and the doctor did not accept the result.The sample was repeated and the result was 173 mmol/l.Clarification was requested to confirm that the results of 146 mmol/l and 173 mmol/l were from the same sample.This information has not been provided.Clarification was requested to confirm which result was considered to be incorrect.This information has not been provided.The customer stated they have been questioning results for 10 other patients tested for na and potassium (k) and are not reporting results from these parameters outside of the laboratory.The customer provided na and k results for 8 other patients.It is not known if repeat testing was performed.No repeat results have been provided.It is not known if an adverse event occurred.No adverse events were alleged.The na electrode was last changed on (b)(6) 2017 during the last annual maintenance.

Manufacturer Narrative

The other 10 patients mentioned are between 18-21 years and between 65-78 years.It was clarified that no comparison testing was performed.The customer heparinizes their sample containers themselves and uses a liquid sodium heparin.Product labeling states to use only heparinized syringes.Improper use of syringes with liquid heparin will affect the parameters, especially the ise parameters.The root cause of the event was the customer's use of liquid sodium heparin to heparinize their sample containers.

Manufacturer Narrative

Some of the results the customer complained about were identified in the data the customer provided, however since the customer provided no clarification around the patient id and the sample used, an exact comparison cannot be made.It does appear that some results for na, potassium, calcium and chloride were abnormally high or low.These results are not being considered for treatment as the customer is not reporting any of these parameters.Calibration data before and during the event were acceptable.Quality controls before and after the event were also acceptable.No instrument or software malfunction was detected.

• 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: 6770438
• MDR Text Key: 83299502
• Report Number: 1823260-2017-01623
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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,Followup
• Report Date: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2017
• 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: 07/11/2017
• 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