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

Catalog Number	04777433001
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable gen.2 ise indirect for na results for 2 patient samples on a cobas c 111 module.The customer was prompted to repeat the samples on another analyzer as they had replaced all ise electrodes prior to patient sample testing.For patient 1, the initial na result was 132 mmol/l.The sample was repeated on a c8000 analyzer and the result was 138 mmol/l.The sample was repeated on the c111 analyzer and the result was 134.7 mmol/l.For patient 2, the initial na result was 132 mmol/l.The sample was repeated on a c8000 analyzer and the result was 138 mmol/l.The sample was repeated on the c111 analyzer and the result was 136.8 mmol/l.No questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The customer replaced the sodium electrode again.The investigation is ongoing.
Additional Manufacturer Narrative
Section d product information has been updated, as well as g1 manufacturing site and g4.The qc recovery data provided showed low sodium results.The customer also replaced the reference electrode and indirect calibrator solutions.The customer's replacement of electrodes and calibrator solutions 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 46250-0457
• MDR Report Key: 18959786
• Report Number: 1823260-2024-00868
• Device Sequence Number: 14597241
• Product Code: JJE
• UDI-Device Identifier: 04015630924769
• UDI-Public: 04015630924769
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• 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): 05/06/2024
• 2 Devices were Involved in the Event: 1 2

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
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/28/2024
• Supplement Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 05/06/2024
• 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