MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 C 702 MODULE; CLINICAL CHEMISTRY ANALYZER

Catalog Number	06473245001
Medical Device Problem Codes	High Test Results (2457); Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reagent lot number is 74213801 with an expiration date of 30-apr-2025.The field service engineer (fse) inspected the functionality of the pressure gauge of the gear pump and performed a carry over needle assessment (cona) test; no issues were noted.He also checked the reagent pipetter flow path and replaced and adjusted the valves.Degasser and ultrasonic mixer (usm).He checked the cleaning and performed another cona test; the results were within specifications.He also checked the water for co2 and verified there was no bacterial contamination.He replaced and adjusted the reagent probes and verified the adjustment of the reagent probe outside the rinse.He performed another cona test and the result was within specifications.He checked for the horizontal and vertical movement of the reagent heads on the r1 drive rail; no issues were noted and the cona test was within specifications.He checked the reagent syringe; no issues were noted and the cona test was within specifications.The fse noted that the event was common to the customer's three c 702 modules and suspected that the increased concentration of co2 in the air in the laboratory may have caused the event.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable creatinine (creaj2) assay results from six patient samples tested on the cobas 8000 c702 module.The reporter was able to provide two patient samples with discrepant results.The patient samples were rerun on their other cobas 8000 c702 module.Sample (b)(6).The initial result from the module was 0.91 mg/dl.The repeat result from the other module was 0.63 mg/dl.Sample (b)(6).The initial result from the module was 0.92 mg/dl.The repeat result from the other module was 0.62 mg/dl.
Additional Manufacturer Narrative
The investigation reviewed the hardware performance check (hpc) results with indications for reagent carry-over.The cause of the event could not be determined. .
Additional Manufacturer Narrative
H6 - investigation findings code was updated.

• Brand Name: COBAS 8000 C 702 MODULE
• Common Device Name: 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: 18807134
• Report Number: 1823260-2024-00590
• Device Sequence Number: 20656744
• Product Code: JJE
• UDI-Device Identifier: 04015630930845
• UDI-Public: 04015630930845
• Combination Product (Y/N): Y
• Initial Reporter Country: PL
• PMA/510(K) Number: K100853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/12/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 06473245001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2024
• Supplement Date Received by Manufacturer: 03/15/2024; 05/29/2024
• Initial Report FDA Received Date: 02/29/2024
• Supplement Report FDA Received Date: 04/03/2024; 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown