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

Catalog Number 03337154001

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/03/2021

Event Type  malfunction  

Manufacturer Narrative

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Event Description

The initial reporter complained of discrepant results for 1 patient tested for pco2 on a cobas b221 instrument compared to a cobas b123 instrument.The cobas b123 system is not sold or available for sale in the us.The result from the b221 was 71.3 mmhg.The result from the b123 was 81.1 mmhg.The results were from 2 different samples obtained approximately 20 minutes apart.It is not clear which result was believed to be correct.The pco2 cassette lot number and expiration date were not provided.

Manufacturer Narrative

Two different arterial blood samples were measured for the same patient and tested on the b221 instrument and a b123 instrument; both were syringe measurements.The sample container was provided as a gas syringe with lyophilized lithium heparin.For the b221 instrument: no correlation factors were applied.It is unknown when the pco2 electrode was installed and the lot number was not provided.During a review of the results obtained on both the b221 and the b123 instruments: the po2 and pco2 parameters were measured higher on the b123 and ph was measured lower.Both instruments showed an fio2 of 0.85.The fio2 results could indicate non-invasive respiratory support to the patient due to respiratory difficulties.The increased po2 amount measured on the b123 instrument could have occurred due to the respiratory support and the decrease in the ph value caused the normal physiological increase in pco2.Different samples from the same patient may show different results due to the patient's health status changing in the time between the two measurements.If liquid heparin was still in the syringe when the sample for the b221 was obtained, there is a risk of over diluting the sample which could cause low pco2 results.Based on the hct (18.5%) and thb (3.8 g/dl) results from the b221 instrument it was determined the sample had a lower amount of red blood cells and was likely diluted compared to the sample run on the b123 instrument.The lower glucose (140 mg/dl) and higher lactate (1.4 mmol/l) results from the b123 instrument indicate the blood composition changed slightly along with the higher pco2 result indicating respiratory acidosis.For the b221 instrument: the pco2 calibration are stable from (b)(6) 2021 through (b)(6)-2021.The pco2 electrode was replaced on (b)(6)-2021 with electrode lot number 21511465.For the b221 instrument: a system stop alarm was observed on (b)(6)-2021 2 hours prior to the low pco2 result and 2 hours after the low pco2 result.This alarm indicates that the sample sensor recognized an insufficient amount of rinse solution during the rinse procedure.No system stop alarm occurred for the alleged sample that could have influenced the pco2 result.For the b221 instrument: qc data for pco2 showed all values were in range prior to and on (b)(6)-2021.Based on the investigation of the database files, no instrument or electrode related issue occurred that could have caused a discrepant pco2 result.Based on the low hct result of 18.5% and the low thb of 3.8 g/dl on the b 221 instrument the event is consistent with a diluted sample due to a pre-analytical handling issue.It is likely that the sample measured on the b 221 was diluted by the anticoagulant or by another substance.The investigation did not identify a product problem with the b 221 instrument.

• 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: 12438909
• MDR Text Key: 273123224
• Report Number: 1823260-2021-02637
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 04015630018345
• UDI-Public: 04015630018345
• 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: 10/04/2021

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: 08/19/2021
• Initial Date FDA Received: 09/08/2021
• Supplement Dates Manufacturer Received: 10/01/2021
• Supplement Dates FDA Received: 10/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1