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 07/20/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is currently ongoing.The event occurred in: (b)(6).

Event Description

The initial reporter complained of a questionable bilirubin result for 1 patient when comparing the result from cobas b 221<6>=roche omni s6 system compared to a cobas 4000 c (311) stand alone system.This medwatch will cover the cobas b221.Please refer to the medwatch with patient identifier (b)(6) for information on the cobas c311.The bilirubin result from the cobas b221 was 13.9 mg/dl.The bilirubin result from the cobas c311 was 18.6 mg/dl.It was not clear which or if either of the instruments generated the correct result.Clarification has been requested.The result in question was not reported outside of the laboratory.The bilirubin reagent lot information was not provided.

Manufacturer Narrative

Date of event, was updated.The sample container was lithium heparin which is transparent.Sample collection for bilirubin was not followed (avoid direct sunlight).The system calibrations for the coox parameters were all in range before and after the alleged measurement.The instrument database shows that a single level of qc material is run approximately every 4 days.Only levels 1 and 3 are run; no level 2 is run.No qc was performed on the day of the event, (b)(6)2019.The performed qc measurements for level 3 failed for bilirubin parameter before and after the event.The sample measurements before and after the alleged measurement showed error flags for bilirubin.The customer ignored all the instrument, measurement and qc warnings that appeared on the b 221.

• 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: 8893231
• MDR Text Key: 175215591
• Report Number: 1823260-2019-02985
• 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: 11/11/2019

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: 07/22/2019
• Initial Date FDA Received: 08/14/2019
• Supplement Dates Manufacturer Received: 07/22/2019
• Supplement Dates FDA Received: 11/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1