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	02/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer changed the sample probe and increased the extra washes and wash volume.After service, the customer ran five samples with no issues.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable high ggt-2 gamma-glutamyltransferase ver.2 results from the cobas c111 analyzer.Sample 1 initial result was 138.4 ku/l and the repeat result was 9.1 ku/l.From a cobas c501 analyzer, the result was 11 ku/l.On (b)(6) 2022, sample 2 initial result was 87.5 ku/l and the repeat result was 26.5 ku/l.From a cobas c501 analyzer, the result was 23 ku/l.The questionable results were not reported outside of the laboratory.The reagent lot number and expiration date were requested but were not provided.
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: 13800440
• Report Number: 1823260-2022-00733
• Device Sequence Number: 14704602
• Product Code: JJE
• UDI-Device Identifier: 04015630927036
• UDI-Public: 04015630927036
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K063744
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 04/25/2022

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: 02/24/2022
• Supplement Date Received by Manufacturer: 04/06/2022
• Initial Report FDA Received Date: 03/17/2022
• Supplement Report FDA Received Date: 04/25/2022
• 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