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

Model Number	C311
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The last calibration performed on (b)(6) 2022 was acceptable.Provided data show that quality control recovery is not stable.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received randomly questionable results for patient urine samples tested with tpuc3 (total protein urine/csf gen.3) on a cobas c 311 analyzer.The following example was provided by the customer.The sample initially resulted in a value of 0.0 mg/dl.The sample was repeated on a different site and resulted in a value of 12 mg/dl.No questionable result was reported outside of the laboratory.The tpuc3 reagent lot was 626934 with an expiration date of 31-jul-2023.
Additional Manufacturer Narrative
Investigation of the reaction monitor shows an unstable reaction.The alarm trace was requested but not provided for the day of the event.The issue is consistent with a handling error as further investigation at the customer's site indicates that someone had altered the measurement limits in the application settings.Per product labeling: "measuring range: 40-2000 mg/l (4 - 200 mg/dl)".The investigation could not identify a product problem.

• 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: 15868549
• Report Number: 1823260-2022-03771
• Device Sequence Number: 5258847
• Product Code: JJE
• UDI-Device Identifier: 04015630919536
• UDI-Public: 04015630919536
• Combination Product (Y/N): N
• Initial Reporter Country: PK
• 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
• Report Date (Section B): 01/25/2023

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 Expiration Date: 07/31/2023
• 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: 11/05/2022
• Supplement Date Received by Manufacturer: 01/03/2023
• Initial Report FDA Received Date: 11/28/2022
• Supplement Report FDA Received Date: 01/25/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DENTACONTAL
• Patient Sex: Unknown