MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 C 701 MODULE; CLINICAL CHEMISTRY ANALYZER

Model Number	C701
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The calibration and qc data provided were acceptable.The reaction monitor showed an abnormal, conspicuous reaction at the time of the initial result.Based on the available data, a product issue could be excluded.The field service engineer (fse) checked the cell and probe wash and exchanged cells and seals at the washing station.The customer performed qc successfully.The service maintenance actions performed by the fse resolved the issue.No further issues were reported after the service visit.Na.
Event or Problem Description
There was an allegation of questionable crej2 creatinine jaffé gen.2 results for 1 patient sample on a cobas 8000 cobas c 701 module.On (b)(6) 2023, the initial crej2 result from module 2 was 0.18 mg/dl.On (b)(6) 2023, the sample was repeated on module 2 and the result was 1.28 mg/dl.The sample was repeated a second time on module 1 and the result was 1.05 mg/dl.No questionable results were reported outside of the laboratory.The reagent lot is 677539 and the expiration date is 31-aug-2024.

• Brand Name: COBAS 8000 C 701 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: 16486763
• Report Number: 1823260-2023-00671
• Device Sequence Number: 20562654
• Product Code: JJE
• UDI-Device Identifier: 04015630930777
• UDI-Public: 04015630930777
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/06/2023

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: C701
• Device Catalogue Number: 05641489001
• 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: 02/06/2023
• Initial Report FDA Received Date: 03/06/2023
• 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