MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS C 303 ANALYTICAL UNIT; CLINICAL CHEMISTRY ANALYZER

Catalog Number	08057877190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hdlc4 reagent lot number was 740519, the cholesterol reagent lot number was 732883, and the triglyceride reagent lot number was 749021.The expiration dates were requested but were not provided.General reagent issues could be ruled out as the calibration and qc data were acceptable for all three assays.The field service engineer adjusted the reagent probe and performed a precision check which was acceptable.The investigation determined the service actions resolved the issue.
Event or Problem Description
There was an allegation of questionable results from the cobas pure c 303 analytical unit.The initial hdlc4 result was 38.2 mg/dl and the repeat result was 76.9 mg/dl.The initial cholesterol result was 283 mg/dl and the repeat result was 161 mg/dl.The initial triglyceride result was 249 mg/dl and the repeat result was 58.1 mg/dl.

• Brand Name: COBAS C 303 ANALYTICAL UNIT
• 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 46250-0457
• MDR Report Key: 18508642
• Report Number: 1823260-2024-00138
• Device Sequence Number: 7948395
• Product Code: JJE
• UDI-Device Identifier: 07613336121306
• UDI-Public: 07613336121306
• Combination Product (Y/N): Y
• Initial Reporter Country: GR
• PMA/510(K) Number: K220134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 01/12/2024

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: 08057877190
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/27/2023
• Initial Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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