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

Model Number	C311
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a questionable ise indirect gen 2 potassium result from the cobas 4000 c (311) analyzer.The initial result was 5.48 mmol/l and was reported outside of the laboratory.The doctor questioned the result and the repeat result was 4.19 mmol/l.A new sample was drawn from the patient and the result matched the repeat result.No specific data was provided.The electrode lot number was j46 with an expiration date of 24-may-2023.
Additional Manufacturer Narrative
The investigation is ongoing.
Additional Manufacturer Narrative
The field service engineer found the customer did not install the seal on the sample probe when it was replaced.He installed the seal and adjusted the sample probe.The customer ran calibration and qc and all results were within specifications.The investigation determined the service actions resolved the issue.As the qc recovery was within the acceptable range, there was no indication of a performance issue with the reagent.

• 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: 16016575
• Report Number: 1823260-2022-04112
• Device Sequence Number: 5767456
• Product Code: JJE
• UDI-Device Identifier: 08430215011539
• UDI-Public: 08430215011539
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K060373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2023

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: 11/30/2022
• Supplement Date Received by Manufacturer: 01/04/2023
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 01/05/2023
• 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 Age: 57 YR
• Patient Sex: Male