MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 C501 MODULE; CLINICAL CHEMISTRY ANALYZER

Catalog Number 04745914001

Device Problems High Readings (2459); Non Reproducible Results (4029)

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

Event Date 07/10/2023

Event Type  malfunction  

Manufacturer Narrative

The reagent lot number is 653007.The expiration date is 30-jun-2024.The field service engineer (fse) inspected the module and did not find any issues with the mechanical adjustments of the reagent and sample pipettors; and the rinse station.He also checked the gear pump pressure and noted that it was within specifications.He checked the rinse mechanism and found that one of the nozzles tube rinse which was linked to the second detergent mixer was torn at the end causing overflow on the cuvettes.He then replaced the tube.He performed rinse mechanism checks and a cell detergent prime with successful results; no overflow was noted.The customer performed qc with successful results.The investigation is ongoing.

Event Description

The initial reporter received a questionable hdlc4 hdl-cholesterol plus 4th generation result from one patient sample tested on the cobas 6000 c501 module.The initial result was reported outside of the laboratory.The physician noted during the patient's consultation that the result was too high and requested the reporter to rerun the patient sample.On (b)(6) 2023, the initial result was 127.1 mg/dl.On (b)(6) 2023, the first repeat result was 45.1 mg/dl.This result was considered compatible with the patient's other lipid results.On (b)(6) 2023, the second repeat result was 46.4 mg/dl.

Manufacturer Narrative

The investigation excluded reagent issues.After service, no further issues were reported by the customer.The investigation determined the service actions resolved the issue.The investigation determined that the event was related to service maintenance.

• Brand Name: COBAS 6000 C501 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: 17540818
• MDR Text Key: 321068283
• Report Number: 1823260-2023-02611
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 04015630924707
• UDI-Public: 04015630924707
• Combination Product (y/n): Y
• Reporter Country Code: VM
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04745914001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2023
• 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