MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS C111; 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	01/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable ise indirect gen.2 sodium results from the cobas c 111 with ise analyzer.The samples were repeated on a cobas c501 analyzer at another site.Patient 1 initial result was 132 mmol/l and the repeat result was 140 mmol/l.Patient 2 initial result was 129 mmol/l and the repeat result was 137 mmol/l.Patient 3 initial result was 132 mmol/l and the repeat result was 140 mmol/l.It was requested but was not known if any of the questionable results were reported outside of the laboratory.The electrode lot number and expiration date were requested but were not provided.
Additional Manufacturer Narrative
The investigation is ongoing.
Additional Manufacturer Narrative
The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: COBAS C111
• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13590242
• Report Number: 1823260-2022-00493
• Device Sequence Number: 12249857
• Product Code: JJE
• UDI-Device Identifier: 04015630924769
• UDI-Public: 04015630924769
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• 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): 03/18/2022

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: 02/01/2022
• Supplement Date Received by Manufacturer: 03/01/2022
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 03/19/2022
• 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