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 02/11/2019

Event Type  malfunction  

Manufacturer Narrative

The event occurred in (b)(6).

Event Description

The initial reporter complained of questionable low potassium (k+) results for multiple patients from 3 different cobas b 221 6 roche omni s6 systems compared to the laboratory results from a siemens advia 2400.From the 70 patient results provided from cobas b211 serial number (b)(4), 44 were a reportable malfunction.From the 43 patient results provided from cobas b211 serial number (b)(4), 1 was a reportable malfunction.From the 33 patient results provided from cobas b211 serial number (b)(4), 5 were a reportable malfunction.This medwatch will cover cobas b211 serial number (b)(4).Refer to the medwatch with patient identifier (b)(6) for information on cobas b211 serial number (b)(4).Refer to the medwatch with patient identifier (b)(6) for information on cobas b211 serial number (b)(4).It was unknown if any of the erroneous results were reported outside of the laboratory.There was no information provided to reasonably suggest that there were any adverse events.Clarification has been requested.The potassium electrode lot information was requested but was not provided.The investigation is currently ongoing.

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.For each pair of alleged measurements, long delays from 1 hour up to several hours were observed.Time delays between measurements of 30 minutes or more can lead to increased k in the serum sample.It was likely the difference in the results was due to the two different sample types (whole blood vs.Serum) and the time difference between measurements.

• 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: 8463736
• MDR Text Key: 140296475
• Report Number: 1823260-2019-01252
• 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: 06/24/2019

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: 03/12/2019
• Initial Date FDA Received: 03/29/2019
• Supplement Dates Manufacturer Received: 03/12/2019
• Supplement Dates FDA Received: 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1