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

Model Number	C502
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter complained of calibration and qc issues with trigl triglycerides (trigl) on a cobas 8000 c 502 module.Due to these issues, the customer repeated patient samples.The customer provided an example of discrepant results for 1 patient sample.The initial trigl result was 57 mg/dl.This result was reported outside of the laboratory.On 17-nov-2022 the repeat result was 92 mg/dl.This result was believed to be correct.The trigl reagent lot number was 64844301 with an expiration date of 31-jul-2023.
Additional Manufacturer Narrative
The customer noted there may be possible contamination from the water supply; the issue started after service was performed on the customer¿s water system.Since service was performed, the customer has to calibrate frequently.The investigation is ongoing.
Additional Manufacturer Narrative
It was determined the customer's water system underwent maintenance activities prior to generating the questionable results.When the water filters are changed, there is a need to flush the system straight to waste before introducing the water system to the analyzers.The issue has been resolved at the customer site.Water system requirements are within the customer's responsibility.The investigation did not identify a product problem.

• Brand Name: COBAS 8000 C 502 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: 15953046
• Report Number: 1823260-2022-03959
• Device Sequence Number: 7427237
• Product Code: JJE
• UDI-Device Identifier: 04015630918393
• UDI-Public: 04015630918393
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K100853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2022

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: C502
• Device Catalogue Number: 05964067001
• 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: 11/17/2022
• Supplement Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 12/09/2022
• Supplement Report FDA Received Date: 12/29/2022
• 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