MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 C (501) MODULE; CLINICAL CHEMISTRY ANALYZER

Catalog Number 05860636001

Device Problems Low Test Results (2458); Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/20/2024

Event Type  malfunction  

Manufacturer Narrative

The reagent lot numbers and expiration dates were requested, but not provided.The investigation is ongoing.

Event Description

The initial reporter stated they received discrepant results for three patient samples tested for multiple analytes on the cobas 6000 c (501) module.Results for the following assays were affected: cobas integra glucose hk gen.3, total protein/total protein stat, alb2 albumin gen.2, and lact2 (lactate).No questionable results were reported outside of the laboratory.The customer noticed exceptionally low test results, so the samples were repeated.The samples were repeated on a second analyzer and these values were deemed correct.The first sample initially resulted in a glucose value of 9 mg/dl and it repeated as 90 mg/dl.The second sample initially resulted in a total protein value of 4.9 g/dl and it repeated as 7.0 g/dl.This sample initially resulted in an albumin value of 2.7 g/dl and it repeated as 3.9 g/dl.The third sample initially resulted in a lactate value of 0.2 mmol/l and it repeated as 0.9 mmol/l.

Manufacturer Narrative

The field service engineer found a bent probe and nozzle.The probe was also contaminated.The system was decontaminated and the rinse levels were adjusted.The sample probe and reagent nozzle were replaced.Mechanism checks and a hardware check were performed and passed.The customer ran calibration and controls; these passed.The investigation determined the service actions resolved the issue.

• Brand Name: COBAS 6000 C (501) MODULE
• Type of Device: 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; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18847635
• MDR Text Key: 337021842
• Report Number: 1823260-2024-00674
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05860636001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1