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

Catalog Number	05122287001
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred in (b)(6).
Event or Problem 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.
Additional 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
• Common Device Name: BLOOD GAS ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7960588
• Report Number: 1823260-2018-03627
• Device Sequence Number: 1487649
• Product Code: CHL
• UDI-Device Identifier: 04015630036950
• UDI-Public: 04015630036950
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K111188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 05122287001
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/20/2018
• Supplement Date Received by Manufacturer: 09/20/2018
• Initial Report FDA Received Date: 10/12/2018
• Supplement Report FDA Received Date: 12/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1