MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS C 111 ANALYZER WITH ISE; CLINICAL CHEMISTRY ANALYZER

Catalog Number	04777433001
Medical Device Problem Codes	Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable ise indirect na for gen.2 results from an unspecified number of patient samples tested on the cobas c 111 with ise.The reporter stated they changed the sodium and reference electrode last week because their ion-selective electrode (ise) calibrations would often fail several times.The qc results would pass after a successful calibration.The reporter stated that they have high/unstable sodium patient results from the analyzer.The reporter was able to provide the following examples of discrepant results: sample 1: on (b)(6) 2023, the initial sodium result was 147 mmol/l.This result was reported.The repeat result was 138.5 mmol/l.Sample 2: on (b)(6) 2023, the initial sodium result was 124.7 mmol/l with a data flag.The first repeat result was 148.4 mmol/l.The second repeat result was 137.0 mmol/l.The third repeat result was 138.2 mmol/l.This result was reported.Sample 3: the initial sodium result was 185 mmol/l with a data flag.The first repeat result was 155 mmol/l.The second repeat result was 150 mmol/l.The third repeat result was 139 mmol/l.Sample 4: the initial sodium result was 150 mmol/l.The repeat result was 141 mmol/l.
Additional Manufacturer Narrative
The electrode lot number is 31231148.The investigation reviewed the error log files and found an indication of a possible general ion-selective electrode (ise) maintenance issue.The following errors were identified: the initialization of the ise unit failed due to a fluid transport problem.The ise reference sensor detected air when the ise reference solution was transported.Air was detected in the fluid system.On the field service engineer's (fse) first service visit, he noted that the air pump pressure was not within specifications.He then replaced the air pump.He performed calibrations.Qcs and parallel runs of patient samples with successful results.The issue was not resolved.On the fse's second visit, he noted that the ise was still unstable.The fse determined that the event was caused by a problem in the printed circuit board (pcb).He then replaced the pcb¿s ise control and ise preamplifier circuit board.The investigation determined that the event was caused by a problem with the electronic circuit boards.After service, no further issues were reported by the customer.The investigation determined the service actions resolved the issue.

• Brand Name: COBAS C 111 ANALYZER WITH ISE
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE INSTRUMENT CENTER AG TEGIMENTA; forrenstrasse; rotkreuz 6343 ; WZ 6343
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 17718979
• Report Number: 1823260-2023-02935
• Device Sequence Number: 7176678
• Product Code: JJE
• UDI-Device Identifier: 04015630924769
• UDI-Public: 04015630924769
• Combination Product (Y/N): Y
• Initial Reporter Country: FI
• PMA/510(K) Number: K071211
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2023

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: 04777433001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2023
• Initial Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown