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

Catalog Number	06473245001
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The magnesium reagent lot number was 769149 and the calcium reagent lot number was 717259.The reagent expiration dates were requested, but not provided.The field service engineer ran mechanism checks.The vacuum, air flow rates, and water pressures were checked.A bent sample probe was replaced.A water supply hose from the water storage tank to the water pump was found kinked.Plastic particles were found in the water supply pump filter, indicating pump head damage.The engineer later returned and replaced pump heads, cleaned the water supply tank, primed the system, and checked probe wash levels.The water pressure was adjusted.Mechanism checks were performed, the vacuum was checked, and the cuvette wash levels were checked.A cell blank calibration and photometer checks were performed.The customer ran calibration and controls.All checks passed.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received questionable results for an unspecified number of patient samples tested with mg2 (magnesium) and ca2 (calcium) on a cobas 8000 c702 module.Examples were provided for two patient samples with discrepant results.The first sample initially resulted in a magnesium value greater than the high end of the assay measuring range (> 2.0 mmol/l).No specific result was provided for the initial value.The sample was repeated with automatic dilution, resulting in a magnesium value of 0.8 mmol/l.The sample was also repeated on a second analyzer, resulting in a magnesium value of 0.8 mmol/l.The second sample resulted in calcium values of 2.049 mmol/l and 1.661 mmol/l.
Additional Manufacturer Narrative
The investigation determined that the issue is consistent with insufficient operator maintenance.

• 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; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18702691
• Report Number: 1823260-2024-00430
• Device Sequence Number: 12310735
• Product Code: JJE
• UDI-Device Identifier: 04015630930845
• UDI-Public: 04015630930845
• Combination Product (Y/N): Y
• Initial Reporter Country: EI
• 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
• Report Date (Section B): 02/21/2024

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: 06473245001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/01/2024
• Supplement Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 02/21/2024
• 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