MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS C111; CLINICAL CHEMISTRY ANALYZER

Model Number	C111
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer replaced a sensor and this resolved reagent bottle liquid level detection errors the customer received.
Event or Problem Description
The initial reporter stated they received discrepant results for two patient samples tested with crej2 creatinine jaffé gen.2 (compensated) on a cobas c 111.The sample initially resulted in a creatinine value of 4.6 mg/dl and this value was reported outside of the laboratory to the clinician.The clinician questioned the result.On 02-mar-2022, the reagent bottle had 8 tests remaining and was replaced.The sample was then repeated on 02-mar-2022, resulting in a value of 1.0 mg/dl.The second sample initially resulted in a creatinine value of 5.8 mg/dl on 10-mar-2022 and repeated as 0.9 mg/dl on 10-mar-2022.No incorrect results were reported outside of the laboratory for this sample.The creatinine reagent lot number was 57929101, with an expiration date of 30-jun-2023.
Additional Manufacturer Narrative
Upon review of the error log files from the instrument, multiple system reagent level detection messages were observed.The field service engineer also observed a sample liquid level detection error.An issue with level detection signal stability was identified.The engineer replaced a transfer head assembly and after this intervention, the instrument performed within specifications.The investigation determined the service actions resolved the issue.

• 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: 13838882
• Report Number: 1823260-2022-00784
• Device Sequence Number: 1403886
• Product Code: JJE
• UDI-Device Identifier: 04015630927036
• UDI-Public: 04015630927036
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K063744
• 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): 04/21/2022

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: 04528778001
• 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: 03/02/2022
• Supplement Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 03/21/2022
• Supplement Report FDA Received Date: 04/21/2022
• 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