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 09/14/2018

Event Type  malfunction  

Manufacturer Narrative

The event occurred in: (b)(6).

Event Description

The customer complained of multiple questionable total hemoglobin (thb) results when comparing the results from a cobas b 123 system and a cobas b 221 analyzer.From the thb data provided for 5 patients, 1 had discrepant results that were a reportable malfunction.This medwatch will cover the cobas b 221 (roche omni s) analyzer.Refer to the medwatch with patient identifier (b)(6) for information on the cobas b 123 system.The thb result from the cobas b123 was 138.8 g/l.The thb result from the cobas b221 was 107.3 g/l.It was unknown if the erroneous result was reported outside of the laboratory.There was no allegation of an adverse event.The investigation is currently ongoing.

Manufacturer Narrative

Qc recovered within acceptable range on the day of the event.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: 8152004
• MDR Text Key: 130631626
• Report Number: 1823260-2018-04791
• 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: 03/07/2019

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: 11/23/2018
• Initial Date FDA Received: 12/11/2018
• Supplement Dates Manufacturer Received: 11/23/2018
• Supplement Dates FDA Received: 03/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1