MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS C 311 ANALYZER; CLINICAL CHEMISTRY ANALYZER

Model Number	C311
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with trigl triglycerides on a cobas 4000 c (311) stand alone system.The sample initially resulted in a triglycerides value of 740.3 mg/dl and this value was reported outside of the laboratory to medical personnel treating the patient.The sample was repeated, resulting in a value of 125.8 mg/dl.The repeat value was considered correct.The triglycerides reagent lot number was 64844301, with an expiration date of 31-jul-2023.
Additional Manufacturer Narrative
The customer confirmed that the sample initially repeated with a value of 124.6 mg/dl.A second repeat was performed after the field service engineer performed actions on the analyzer and this value was 125.8 mg/dl.
Additional Manufacturer Narrative
An additional repeat triglycerides value was provided for the complained sample as 124.6 mg/dl.It was asked, but it is not known if this value was provided in error or if it is an additional repeat value from the sample.
Additional Manufacturer Narrative
The last calibration performed on (b)(6) 2022 was ok.The provided quality control data was within range.Upon review of the alarm trace, no relevant alarms were observed.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: COBAS C 311 ANALYZER
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; na; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15880353
• Report Number: 1823260-2022-03791
• Device Sequence Number: 5399042
• Product Code: JJE
• UDI-Device Identifier: 04015630918393
• UDI-Public: 04015630918393
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• PMA/510(K) Number: K060373
• 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,Followup,Followup
• Report Date (Section B): 01/10/2023

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: C311
• Device Catalogue Number: 04826876001
• 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: 11/11/2022
• Supplement Date Received by Manufacturer: 11/11/2022; 12/06/2022; 01/04/2023
• Initial Report FDA Received Date: 11/29/2022
• Supplement Report FDA Received Date: 12/06/2022; 12/20/2022; 01/10/2023
• 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