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

Model Number	C702
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with the ureal (urea/bun) assay on a cobas 8000 c 702 module.The sample initially resulted in a value of 136.9 mg/dl accompanied by a data flag.The sample was repeated two times, resulting in values of 27.2 mg/dl and 27.4 mg/dl.It is unknown if the questionable result was reported outside of the laboratory.The ureal reagent lot number and the expiration date were requested but not provided.
Additional Manufacturer Narrative
Section b6 was updated.It was confirmed that no questionable result was reported outside of the laboratory.The ureal reagent lot number was 652502 with an expiration date of 30-apr-2023.The last calibration was performed on 10-oct-2022 and was normal with no alarms.The quality control results on the day of the event are normal.Upon review of the alarm trace, several abnormal aspiration and sample short alarms were observed.The investigation is ongoing.
Additional Manufacturer Narrative
The field service engineer performed several service maintenance-related actions and adjustments during three different service visits.After the third service visit, it was confirmed that the issue was solved.The investigation determined the service actions performed resolved the issue.

• 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; na; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15748640
• Report Number: 1823260-2022-03541
• Device Sequence Number: 16858672
• Product Code: JJE
• UDI-Device Identifier: 04015630925131
• UDI-Public: 04015630925131
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 01/23/2023

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 Model Number: C702
• Device Catalogue Number: 06473245001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2022
• Supplement Date Received by Manufacturer: 10/26/2022; 01/02/2023
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 11/17/2022; 01/23/2023
• 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