MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS E 411 IMMUNOASSAY ANALYZER; IMMUNOCHEMISTRY ANALYZER

Catalog Number	04775201973
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The vitamin d total iii reagent expiration date was not provided.The cobas e411 serial number was (b)(6).The customer stated that the analyzer had been pushed and it was not balanced.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 2 patients' serum samples tested with elecsys vitamin d total g3 ( vitamin d total iii) assay on a cobas e411 immunoassay analyzer.Sample 1 (patient 1): initial result: >80 ng/ml.Repeat result: 14.2 ng/ml.Sample 2 (patient 2) was tested on (b)(6) 2024: initial result: >80 ng/ml.Repeat result: 26.0 ng/ml.The physician questioned the results.The samples were then repeated.The repeat results were deemed to be correct.
Additional Manufacturer Narrative
The customer verbally stated that the qc was out of range on (b)(6) 2024 and they believed that the issue start date was on (b)(6) 2024.The field service engineer moved and adjusted the instrument to be leveled and unmovable.He then powered on the instrument and performed a system volume check.The check was successful.The root cause was due to the analyzer being pushed back six inches causing the analyzer to be knocked off its pads.The service actions (moving and adjusting the instrument to be leveled and unmovable) resolved the issue.No further issues were reported afterward.

• Brand Name: COBAS E 411 IMMUNOASSAY ANALYZER
• 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 46250-0457
• MDR Report Key: 18787498
• Report Number: 1823260-2024-00553
• Device Sequence Number: 18067910
• Product Code: JJE
• UDI-Device Identifier: 07613336184615
• UDI-Public: 07613336184615
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K961481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2024
• 2 Devices were Involved in the Event: 1 2

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: 04775201973
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2024
• Supplement Date Received by Manufacturer: 03/22/2024
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 04/05/2024
• 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 Age: 62 YR
• Patient Sex: Female