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

Catalog Number 05860636001

Device Problem Low Test Results (2458)

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

Event Date 02/24/2024

Event Type  malfunction  

Event Description

The initial reporter complained of discrepant results for 1 patient sample tested for na electrode (na), cl electrode (cl), and k electrode (k) on a cobas 6000 c (501) module.The initial na result was 100 mmol/l.The repeat result was 136 mmol/l.The initial cl result was 63.3 mmol/l.The repeat result was 99.5 mmol/l.The initial k result was 2.81 mmol/l.The repeat result was 4.18 mmol/l.The sample was repeated due to a negative anion gap.The questionable results were not reported outside of the laboratory.The repeat results were believed to be correct.

Manufacturer Narrative

There were no issues with any other tests run on this patient sample.The na electrode lot number was s82 with an expiration date of 31-sep-2024.The cl electrode lot number was n91.The expiration date was not provided.The k electrode lot number was b78.The expiration date was not provided.Calibration was last performed on 05-mar-2024 with acceptable results.Qc was acceptable.No issues were identified during a review of the alarm trace data.On 25-feb-2024 the field service engineer (fse) found a clogged solenoid valve bank and vacuum tubing which were replaced.On 27-feb-2024 the fse found air within the electrodes; these were flushed.The customer replaced the pinch tubing and the electrodes.The customer has had no further issues.

Manufacturer Narrative

The investigation determined the service/customer maintenance 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: 18995562
• MDR Text Key: 338888079
• Report Number: 1823260-2024-00942
• 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: 04/15/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 05860636001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 03/28/2024
• Supplement Dates Manufacturer Received: 04/10/2024
• Supplement Dates FDA Received: 04/15/2024
• 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 Sex: Female