MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 4000 C (311) STAND ALONE SYSTEM; CLINICAL CHEMISTRY ANALYZER

Model Number C311

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591); Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2021

Event Type  malfunction  

Manufacturer Narrative

The field service engineer determined the cell rinse and wash nozzles were overfilling the cuvettes.The nozzle rinse dispense volumes were adjusted.Successful precision studies were performed.The customer ran successful calibrations and controls.A mixer check was performed and was successful.

Event Description

The initial reporter stated that they had multiple issues after a service visit performed on (b)(6) 2020.Multiple ise errors, reagent short errors and a mixer power error occurred.The reporter stated they received discrepant results for five patient samples tested with ise indirect na for gen.2.The initial values were reported outside of the laboratory and questioned.The samples were repeated and the repeat results were believed to be correct.Refer to the attachment for all patient data.The na electrode lot number and expiration date were requested, but not provided.

Manufacturer Narrative

The last calibration performed on (b)(6) 2021 was ok.Quality controls were ok.Upon review of the alarm trace, the errors experienced by the customer were observed.The investigation determined the service actions resolved the issue.

• Brand Name: COBAS 4000 C (311) STAND ALONE SYSTEM
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11378570
• MDR Text Key: 249029544
• Report Number: 1823260-2021-00571
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C311
• Device Catalogue Number: 04826876001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR