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

Catalog Number	04777433001
Medical Device Problem Code	Failure to Calibrate (2440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The na electrode lot number and expiration date were not provided.The customer stated that they had biased controls.The investigation is ongoing.
Event or Problem Description
We received an allegation of questionable ise results for 4 patients' samples tested on a cobas c111 with an ise analyzer when compared to a different laboratory.Results for the sodium (na) test were affected.Sample 1 (patient 1): initial result: 128.6 mmol/l.Repeat result: 135.89 mmol/l.Sample 2, sample 3, and sample 4 were tested on (b)(6) 2024: sample 2 (patient 2): initial result: 127 mmol/l.Repeat result: 142 mmol/l.Sample 3 (patient 3): initial result: 129.3 mmol/l.Repeat result: 140.72 mmol/l.Sample 4 (patient 4): initial result: 129.6 mmol/l.Repeat result: 139.26 mmol/l.The physician questioned the initial results after sending new patients' draw to another laboratory.Sample 1, sample 3, and sample 4 were then repeated on (b)(6) 2024.The results obtained from the other laboratory were deemed to be correct.
Additional Manufacturer Narrative
The field service engineer visited the customer's site, replaced multiple ion-selective electrode (ise) components, and tested the samples and compared the results between the c311 and the cobas pure analyzers and the difference was acceptable.No further issues were reported after the service visit.The service actions resolved the issue.The specific cause of the event was not identified.

• 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: 20892520
• Report Number: 1823260-2024-03587
• Device Sequence Number: 12723416
• Product Code: JJE
• UDI-Device Identifier: 04015630924769
• UDI-Public: 04015630924769
• Combination Product (Y/N): N
• Initial Reporter Country: KE
• 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,Followup
• Report Date (Section B): 01/13/2025

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: 11/17/2024
• Supplement Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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