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 02/13/2024

Event Type  malfunction  

Manufacturer Narrative

The serial number of the c501 analyzer is (b)(6).The investigation is ongoing.

Event Description

The initial reporter stated they have been having ongoing issues with quality control recovery for lactate dehydrogenase on the cobas 6000 c (501) module since on (b)(6) 2024.The customer called on (b)(6) 2023 and stated that controls were outside of range, so they re-tested an unspecified number of patient samples that had been processed.A bias was observed after the samples were repeated.The customer provided examples of two patient samples with discrepant ldh results.The first sample initially resulted in an ldh value of 234 u/l.The sample was repeated on a second analyzer on (b)(6) 2024, resulting in a value of 415 u/l.The repeat value was deemed correct.The second sample initially resulted in an ldh value of 324 u/l on (b)(6) 2024.The sample was repeated on a second analyzer on (b)(6) 2024, resulting in a value of 435 u/l.The repeat value was deemed correct.

Manufacturer Narrative

The ldh reagent lot number was 75292901, with an expiration date of 20-sep-2024.The sample centrifugation time was shorter than recommended by the tube manufacturer.The field service engineer determined there was contamination in the analyzer flow path.The flow path was cleaned.The water pressure and rinse levels were adjusted.Mechanical and operational checks passed.The customer ran calibration and controls; all results were within the customer's specifications.The customer had no further issues.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: 18839440
• MDR Text Key: 337427119
• Report Number: 1823260-2024-00656
• 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: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05860636001
• Device Lot Number: 75292901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2024
• 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