MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS E 801 ANALYTICAL UNIT; IMMUNOCHEMISTRY ANALYZER

Catalog Number	08454345001
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received a questionable result for one patient sample tested with the elecsys anti-hcv ii immunoassay on a cobas e 801 analytical unit.The sample initially resulted in an anti-hcv value of 18.1 coi (reactive).The sample was repeated twice, resulting in values of 39.8 coi (reactive) and 0.319 coi (non-reactive).The sample was repeated twice on a second analyzer on (b)(6) 2023, resulting in anti-hcv values of 44.1 coi (reactive) and 40.5 coi (reactive).
Additional Manufacturer Narrative
The customer reported there was an alarm on the analyzer indicating an error in system reagent detection.The field service engineer changed system reagent tubing and ran measuring cell preparation maintenance.The tubing was damaged and there were air bubbles in the tube path to a reagent probe wash station.An instrument check was performed and was correct.A first run of controls had negative values for the positive control.Re-runs were correctly positive for these controls.The investigation determined the service actions resolved the issue.

• Brand Name: COBAS E 801 ANALYTICAL UNIT
• Common Device Name: IMMUNOCHEMISTRY 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: 18343788
• Report Number: 1823260-2023-04061
• Device Sequence Number: 12145280
• Product Code: JJE
• UDI-Device Identifier: 07613336158456
• UDI-Public: 07613336158456
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 12/18/2023

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 Catalogue Number: 08454345001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 12/18/2023
• 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: Female
• Patient Race: White