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

Catalog Number 03337154001

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2019

Event Type  malfunction  

Manufacturer Narrative

Calibration and qc was acceptable.The customer changed the mss cassette and the tubing which was loose.This event occurred in (b)(6).

Event Description

The initial reporter received questionable glucose results for two patients from the cobas b 221 analyzer.Patient a result at 4:21 am was 1.66.The sample was not repeated and diagnosis were based on the results.Patient b result at 10:29 am was 0.6.The sample was not repeated and diagnosis were based on the results.About four hours later, the glucose result from a meter was higher and may have been 13.The customer was not sure which patient this was, the time frame, or the specific result.The results were reported outside of the laboratory.The lot number of the mss reagent cassette was requested but not provided.

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.The ref electrode was installed on the cobas b 221 on (b)(6) 2018 and found to be expired at time of discrepant results.Based on cobas b 221 instructions for use, english version 18.0, page 304, changing the reference electrode: using expired reference electrodes and/or reference electrodes that have exceeded their maximum in-use time may lead to incorrect results the reference electrode produces a stable electrode potential that other electrodes reference to compute their respective voltages.Using expired reference electrodes and/or reference electrodes that have exceeded their maximum in-use time may lead to incorrect results, which may endanger patient lives.The operator did not follow the instructions for use for quality control measurements.Failed qc was found in the data prior to discrepa rntesults.Based on cobas b 221 instructions for use (ifu), english version 18.0, page 185, failure to follow qc protocols or ignoring qc results may lead to incorrect patient results: perform qc tests on 3 levels after each of these actions: replacement of mss cassette, electrode, fluid pack, or rinse solution.

• 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: 9497328
• MDR Text Key: 219764613
• Report Number: 1823260-2019-04471
• 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
• Report Date: 04/02/2020

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: 11/22/2019
• Initial Date FDA Received: 12/19/2019
• Supplement Dates Manufacturer Received: 11/22/2019
• Supplement Dates FDA Received: 04/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1