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

Catalog Number 05860636001

Device Problems High Test Results (2457); Low Test Results (2458)

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

Event Date 02/26/2024

Event Type  malfunction  

Manufacturer Narrative

The na electrode lot number was p96.The expiration date was not provided.The cl electrode lot number was k26.The expiration date was not provided.The field service engineer (fse) found an issue with the sample probe and the slider.The fse replaced the slider and cleaned the sample probe and tube.The customer performed successful qc.The service actions resolved the issue.

Event Description

The initial reporter questioned ise results for 3 patient samples tested on a cobas 6000 c (501) module.Of the data provided, discrepant results were identified for 2 patient samples tested for either na electrode (na) or chloride (cl).Patient 1 initial na result was 80 mmol/l accompanied by an invalidating data flag.The sample was automatically repeated with a result of 132 mmol/l.The sample was repeated on a different module with a result of 142 mmol/l.Patient 2 initial cl result was 309 mmol/l accompanied by an invalidating data flag.The sample was automatically repeated with a result of 307 mmol/l.The sample was repeated on a different module with a result of 104.3 mmol/l.No questionable results were reported outside of the laboratory.The repeat results from the other module were believed to be correct.

• 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: 18851499
• MDR Text Key: 337076909
• Report Number: 1823260-2024-00680
• 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
• Report Date: 03/06/2024

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: 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Sex: Male