MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS VITAMIN D TOTAL III; VITAMIN D ASSAY

Model Number	E601
Medical Device Problem Codes	Degraded (1153); High Test Results (2457); Material Integrity Problem (2978); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer verified that the instrument was operating within specifications.Qc was performed and it qc was successful within range.Precision studies were performed and they were within specifications.The assay performance checks passed in accordance with the documented servicing procedures.
Event or Problem Description
We received an allegation of questionable results for 2 patients' samples tested with vitamin d total g3 (vitamin d3) assay on a cobas 6000 e601.On (b)(6) 2023 the customer ran the patients' samples and reported the following results: sample 1: run 1: 120 ng/ml test, rerun 1: 7.55 ng/ml, rerun 2: 6.55 ng/ml.Sample 2: run 1: 120 ng/ml test, rerun 1: 23.20 ng/ml, rerun 2: 24.35 ng/ml.The results of 120 ng/ml test were reported outside of the laboratory but they did not match the patient's clinical picture.So it was repeated.The result that was deemed to be correct for sample 1 was 7.55 ng/ml.The vitamin d3 lot number was 662797.The expiration date was not provided.
Additional Manufacturer Narrative
The investigation did not identify a product problem.The cause of the event could not be determined.The instrument was operating within specifications and the issue was resolved.

• Brand Name: ELECSYS VITAMIN D TOTAL III
• Common Device Name: VITAMIN D ASSAY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16659186
• Report Number: 1823260-2023-01053
• Device Sequence Number: 7274730
• Product Code: MRG
• UDI-Device Identifier: 07613336184615
• UDI-Public: 07613336184615
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K210901
• 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): 05/01/2023
• 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 Model Number: E601
• Device Catalogue Number: 09038078160
• Device Lot Number: 662797
• 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: 03/06/2023
• Supplement Date Received by Manufacturer: 04/10/2023
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 05/01/2023
• 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 Age: 51 YR
• Patient Sex: Female
• Patient Weight: 54 KG