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

Catalog Number 03337154001

Device Problem Low Test Results (2458)

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

Event Date 03/20/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer complained of questionable low results for 3 patient samples tested for partial pressure of oxygen (po2) on a cobas b 221<6>=roche omni s6 system (b221) in the critical care unit compared to another b221.Of the data provided, 2 patient results were reportable malfunctions.Patient 1 initial po2 was 7.37 kpa.The sample was tested on another b221 5 minutes later in another laboratory with po2 result of 10.13 kpa.Patient 2 initial po2 was 13.21 kpa.The sample was tested on another b221 10 minutes later in another laboratory with po2 result of 19.62 kpa.The initial results were released outside of the laboratory, but were lower than expected.There was no allegation of an adverse event.The samples were sent to the other laboratory using a pneumatic tube system.Qc results on the b221 were acceptable.The customer changed the po2 sensor and a fluid pack.The customer prepared the system for use and with a field engineering specialist that was on site performed comparison testing with acceptable results.

Manufacturer Narrative

The other cobas b221 analyzer serial number was (b)(4).The patients were not treated based on the results from the other analyzer.Further investigation stated that the transport of samples via a pneumatic tube system can lead to increased po2 values (intermixing of small air bubbles due to agitation of sample).The investigation is currently ongoing.

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 7398855
• MDR Text Key: 105160676
• Report Number: 1823260-2018-01065
• 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,Followup
• Report Date: 09/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03337154001
• Initial Date Manufacturer Received: 03/21/2018
• Initial Date FDA Received: 04/05/2018
• Supplement Dates Manufacturer Received: 03/21/2018; 03/21/2018
• Supplement Dates FDA Received: 05/07/2018; 09/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1