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

Catalog Number	09038086190
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The qc recovery data provided was acceptable.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys vitamin d assay results for 2 patient heparin samples from 1 patient on a cobas e 801 analytical unit.The initial vitamin d result was >120 ng/dl with flag.A 1:2 dilution was performed on the sample and result was 11 ng/ml.The customer performed a 5 repetition precision test on the sample and the results were 108 ng/ml, >120 ng/ml with flag, 115 ng/ml, 53.1 ng/ml, and 97.5 ng/ml.A 1:2 dilution was performed on the sample and another 5 repetition precision test was performed.The results were 9.04 ng/ml, 8.7 ng/ml, 10.8 ng/ml, 8.72 ng/ml, and 7.36 ng/ml.A second tube collected from the same patient at the same time was sent to another laboratory and tested on another analyzer.The result was 11 ng/ml.The other lab's reference range is 30-40 ng/ml.The second sample was also tested four times at the customer site and the results were 46.0 ng/ml, 29.8 ng/ml, 40.8 ng/ml, and 33.1 ng/ml.No questionable results were reported outside of the laboratory.The result from the other laboratory was deemed correct.
Additional Manufacturer Narrative
The alarm trace did not contain a conspicuous event.The issue was resolved by the customer changing their test specimen type from lithium heparin tubes to edta tubes.Based on the available data, a general reagent issue could be excluded.The investigation did not identify a product problem.The root cause of the event could not be determined.

• Brand Name: ELECSYS VITAMIN D TOTAL III
• Common Device Name: VITAMIN D TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 19192637
• Report Number: 1823260-2024-01292
• Device Sequence Number: 20923075
• Product Code: MRG
• UDI-Device Identifier: 07613336172650
• UDI-Public: 07613336172650
• Combination Product (Y/N): Y
• Initial Reporter Country: TH
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2024

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 Expiration Date: 05/31/2024
• Device Catalogue Number: 09038086190
• Device Lot Number: 744661
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2024
• Supplement Date Received by Manufacturer: 05/17/2024
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 06/06/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: VITAMIN B COMPLEX.
• Patient Sex: Unknown