MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 C 502 MODULE; CLINICAL CHEMISTRY ANALYZER

Catalog Number 05964067001

Device Problem Low Test Results (2458)

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

Event Date 03/16/2024

Event Type  malfunction  

Manufacturer Narrative

The reagent lot number and the expiration date were requested but not provided.The field service engineer (fse) inspected the module and found a puncture in the vacuum line preventing proper voiding of cuvettes and subsequent overflow.He then inspected all assemblies, adjusted the gear pump pressure, and replaced all of the rinse and vacuum tubings.He performed cell blank measurements, mechanical checks, a calcium carryover test, and precision checks with successful results.After service, no further issues were reported by the customer.The investigation determined the service actions resolved the issue.

Event Description

The initial reporter received questionable calcium (ca, gen.2) results from an unspecified number of patient samples tested on the cobas 8000 cobas c 502 module.The reporter stated that the ca assay patient results were running low.The reporter was able to provide one patient sample with a result discrepancy: the initial result was reported outside of the laboratory.The data flag in the initial result prompted the rerun of the patient sample on their other c 502 module.The initial result from the module was 7.45 mg/dl with a data flag.The first repeat result from the module by auto repeat was 8.56 mg/dl.The second repeat result from the other module was 8.98 mg/dl.This repeat result was deemed correct.

• Brand Name: COBAS 8000 C 502 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: 18993941
• MDR Text Key: 338888191
• Report Number: 1823260-2024-00941
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 04015630928354
• UDI-Public: 04015630928354
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K100853
• 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: 03/28/2024

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: 05964067001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2024
• Initial Date FDA Received: 03/28/2024
• 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