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

Model Number	C111
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided for the investigation.The investigation did not identify a product problem.The cause of the event could not be determined.
Event or Problem Description
The initial reporter questioned low results for an unspecified number of patient samples tested for sodium (na) on a cobas c 111 instrument.The customer provided an example of discrepant results for 1 patient sample.The initial result was 121 mmol/l.The sample was repeated 4 times with results of 124 mmol/l, 126 mmol/l, 130 mmol/l, and 131 mmol/l.No questionable results were reported outside of the laboratory.The na electrode lot number with expiration date was not provided.

• 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; na; rotkreuz 6343 ; SZ 6343
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16978833
• Report Number: 1823260-2023-01711
• Device Sequence Number: 17762436
• Product Code: JJE
• UDI-Device Identifier: 04015630924769
• UDI-Public: 04015630924769
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 05/22/2023

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 Model Number: C111
• Device Catalogue Number: 04777433001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 05/22/2023
• 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