MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 C501 MODULE; CLINICAL CHEMISTRY ANALYZER

Model Number	C501
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with the phos2 (phosphate (inorganic) ver.2) assay on a cobas 6000 c501 module.The reporter also mentioned they have quality control issues in the laboratory.The sample initially resulted in a phos2 value of around 60 mg/dl.The sample was repeated, resulting in a phos2 value of around 30 mg/dl.No questionable result was reported outside of the laboratory.The phos2 reagent lot was 67081901 with an expiration date of 31-jan-2024.
Additional Manufacturer Narrative
Based on the limited information provided, the cause of the event could not be determined.The investigation did not identify a product problem.

• Brand Name: COBAS 6000 C501 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: 15969016
• Report Number: 1823260-2022-03988
• Device Sequence Number: 20068174
• Product Code: JJE
• UDI-Device Identifier: 04015630918973
• UDI-Public: 04015630918973
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K060373
• 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
• Report Date (Section B): 01/06/2023

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 Expiration Date: 01/31/2024
• Device Model Number: C501
• Device Catalogue Number: 04745914001
• Device Lot Number: 67081901
• 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: 11/21/2022
• Supplement Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 01/06/2023
• 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 Sex: Unknown