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

Model Number	C111
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The last calibration performed on (b)(6) 2021 was ok.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with ggt-2-glutamyl transferase ver.2 standardized against ifcc / szasz on a cobas c 111.The sample initially resulted in a ggt value of 362.4 u/l and this value was reported outside of the laboratory.The sample was repeated on (b)(6) 2022, resulting in a value of 9.9 u/l.The repeat value agreed with the patient's clinical picture.The ggt reagent lot number was 530461-01.The reagent expiration date was requested, but not provided.
Additional Manufacturer Narrative
Quality control data for one level was provided for dates 07-feb-2022 to 13-feb-2022; the results were ok.Upon review of analyzer data, there was no indication of a technical issue.The investigation could 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: 13685033
• Report Number: 1823260-2022-00591
• Device Sequence Number: 5110768
• Product Code: JJE
• UDI-Device Identifier: 04015630924769
• UDI-Public: 04015630924769
• Combination Product (Y/N): N
• Initial Reporter Country: HR
• 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): 04/14/2022

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: 02/10/2022
• Supplement Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 03/07/2022
• Supplement Report FDA Received Date: 04/14/2022
• 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