MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS B 123 <4> SYSTEM; BLOOD GAS ANALYZER

Catalog Number 05122287001

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/20/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer complained of discrepant sodium (na) results for 1 patient tested on a cobas b 123 system compared to a beckman coulter analyzer.The na result from the beckman coulter analyzer at 1:59 p.M.Was 162 mmol/l.A sample was obtained at 1:59 p.M.For the cobas b 123 instrument and the na result at 2:09 p.M.Was 152 mmol/l.The customer performed comparison testing with the patient sample for troubleshooting purposes on 4 other cobas b123 instruments: cobas b 123 #1 at 2:11 p.M.Was 156 mmol/l, cobas b 123 #2 at 2:17 p.M.Was 159 mmol/l, cobas b 123 #3 at 2:31 p.M.Was 161 mmol/l, cobas b 123 #4 at 2:37 p.M.Was 161 mmol/l.The customer is concerned with the lower na result of 152 mmol/l from the b 123 instrument in question.There was no allegation that an adverse event occurred.Qc and calibration were acceptable.The na electrode lot number and expiration date were not provided.

Manufacturer Narrative

The log files were investigated and it was determined the customer did not apply the recommended correlation factors when comparing measurements from cobas b 123 to a lab analyzer.Retention testing of the lot of na sensors involved met specifications.The investigation did not identify a product problem.A specific root cause could not be determined.

• Brand Name: COBAS B 123 <4> SYSTEM
• Type of Device: BLOOD GAS ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7960588
• MDR Text Key: 125930269
• Report Number: 1823260-2018-03627
• Device Sequence Number: 1
• Product Code: CHL
• UDI-Device Identifier: 04015630036950
• UDI-Public: 04015630036950
• Combination Product (y/n): N
• PMA/PMN Number: K111188
• 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: 12/26/2018

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: 05122287001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/20/2018
• Initial Date FDA Received: 10/12/2018
• Supplement Dates Manufacturer Received: 09/20/2018
• Supplement Dates FDA Received: 12/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1