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

Model Number	C502
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The ca2 reagent lot was 71224101 with an expiration date of 31-may-2024.The field service engineer performed a mechanism check and verified the cuvette washing/rinse and gear pump pressure; there were no abnormalities.The sample and reagent needles were checked and a loose reagent probe was found and adjusted.The sample arm and rinse tube assembly were exchanged.A new sample probe was installed and mechanical adjustments were performed.The lamp and cuvettes were changed.Quality controls were run with acceptable results.The instrument was confirmed to be running back within specifications.The investigation determined the service actions resolved the issue.H3 other text.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with the ca2 (calcium gen.2) assay on a cobas 8000 cobas c 502 module.The sample initially resulted in a ca2 value of 1.269 mmol/l.A second sample collected from the same patient was tested, resulting in a ca2 value of 2.353 mmol/l.The initial sample was then repeated on the same and a second module, resulting in ca2 values of 2.97 mmol/l and 2.254 mmol/l.

• 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: 17265638
• Report Number: 1823260-2023-02181
• Device Sequence Number: 12777975
• Product Code: JJE
• UDI-Device Identifier: 04015630942565
• UDI-Public: 04015630942565
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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
• Report Date (Section B): 07/06/2023

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: C502
• Device Catalogue Number: 05964067001
• Device Lot Number: 68804601
• 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: 06/08/2023
• Initial Report FDA Received Date: 07/06/2023
• 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 Age: 69 YR
• Patient Sex: Female