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

Model Number	C111
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with alp2s alkaline phosphatase acc.To ifcc gen.2 on a cobas c 111.The sample initially resulted in an alp value of 412 u/l and this value was reported outside of the laboratory to the patient.The sample was sent to another laboratory for testing and alp testing of the sample was repeated twice on an unknown analyzer, resulting in values of 188 u/l and 182 u/l.The sample was transferred back to the customer's laboratory and it was repeated on the c 111 analyzer on (b)(6) 2022, resulting in a value of 186 u/l.The sample was also repeated on a cobas 4000 c (311) stand alone system at the customer site, resulting in a value of 189 u/l.The alp reagent lot number was 57010401.The reagent expiration date was requested, but not provided.
Additional Manufacturer Narrative
A corrected report was issued after repeat of the sample.Upon review of data files from the analyzer, a specific instrument product problem could not be determined.All provided data was within specifications.There was no evidence of an instrument issue.An issue with pre-analytic sample handling could not be ruled out.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: COBAS C 111 ANALYZER
• 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: 14403808
• Report Number: 1823260-2022-01396
• Device Sequence Number: 5606838
• 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): 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): 06/27/2022

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: 04/27/2022
• Supplement Date Received by Manufacturer: 06/03/2022
• Initial Report FDA Received Date: 05/15/2022
• Supplement Report FDA Received Date: 06/27/2022
• 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