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 02/13/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).

Event Description

The customer stated that they received questionable low results for an unspecified number of patient samples tested for partial pressure of oxygen (po2) on the cobas b 221<6>=roche omni s6 system (b221) in the critical care unit.The customer provided data for five patient samples that had erroneous po2 results.Erroneous results are reported outside of the laboratory.Po2 was the only test parameter that was affected.All samples were initially tested on the b221 analyzer and the po2 results were low.The samples were repeated on a second b221 analyzer used in the laboratory.The fifth patient sample was tested after deproteinizer and system reagents were changed on both analyzers.Samples are injected into the analyzer and they make sure there is no air in them.The lot number and expiration date of the po2 electrode/cartridge was asked for, but not provided.The field service engineer checked the analyzer.He ran a patient sample comparison after checking the analyzer.

Manufacturer Narrative

No medical treatment was changed based on the po2 result.No adverse events were alleged.The electrode had been changed on (b)(6) 2018.On (b)(6) 2018, the field service engineer completed preventive maintenance on the analyzer.All affected patients were on varying degrees of oxygen while samples were collected for testing.

Manufacturer Narrative

The higher po2 results measured on the second cobas b221 could be partially due to the delay between measurements.These delays in measurement were between 12 and 31 minutes later.Also the effect of sample transport from the ward to the laboratory cannot be excluded.No details about the transport could be provided.No other influence could be determined.Calibration and qc were acceptable.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: 7309151
• MDR Text Key: 101700928
• Report Number: 1823260-2018-00630
• 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,Followup
• Report Date: 09/13/2018

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/13/2018
• Initial Date FDA Received: 03/02/2018
• Supplement Dates Manufacturer Received: 02/13/2018; 02/13/2018; 02/13/2018
• Supplement Dates FDA Received: 03/27/2018; 04/04/2018; 09/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1