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 02/27/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6) - (b)(4).

Event Description

The initial reporter received questionable low glucose results for quality control material and one patient sample from the cobas b 221 6 roche omni s6 system.At 13:32, the result from the cobas b221 was 1.21 mmol/l.At 13:36 and 13:38, the results from an inform ii meter were 7 mmol/l and 6.7 mmol/l.There was no allegation of an adverse event.The lot number and expiration date of the mss cassette in use were requested but were not provided.White deposits could be seen on the analyzer.The customer replaced the mss cassette.The field service representative cleaned the analyzer, mss input, electrode, and the electrode holder.He inspected the cartridge and found no visible contamination.He performed calibration and qc which were acceptable.

Manufacturer Narrative

The calibration signals for cal1 and cal2 were stable during the time frame the affected sample was run.Before the affected sample was run, several qc measurements failed.Qc was repeated, and was within specification.The mss chamber was requested for investigation and the investigation was unable to reproduce the customer¿s error pattern.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
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 8419897
• MDR Text Key: 138777695
• Report Number: 1823260-2019-01066
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K032311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/20/2019

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2019
• Initial Date FDA Received: 03/14/2019
• Supplement Dates Manufacturer Received: 02/27/2019
• Supplement Dates FDA Received: 08/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1