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

Catalog Number	09038078160
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable elecsys vitamin d total iii results from an unspecified number of patient samples tested on two cobas 6000 e601 modules (cobas 1 and cobas 2).One patient sample with discrepant results was provided: results from the cobas 1: the initial result of the undiluted patient sample was 120.0 ng/ml with a data flag.The first repeat result of the undiluted patient sample was 120.0 ng/ml with a data flag.The second repeat result with the patient sample at manual 1:2 dilution was 120.0 ng/ml with a data flag.The second repeat result with the patient sample at manual 1:10 dilution was 23.30 ng/ml with a final calculated result of 233.0 ng/ml.Results from cobas 2: the initial result of the undiluted patient sample was 120.0 ng/ml with a data flag.The first repeat result of the undiluted patient sample was 120.0 ng/ml with a data flag.The second repeat result with the patient sample at manual 1:2 dilution was 120.0 ng/ml with a data flag.The second repeat result with the patient sample at manual 1:10 dilution was 23.44 ng/ml with a final calculated result of 234.4 ng/ml.
Additional Manufacturer Narrative
The serial number of cobas 1 is (b)(6).The serial number of cobas 2 is (b)(6).Cobas 1 the field service engineer (fse) inspected the module but did not establish the event's cause.He flushed the syringe flow paths and checked the alignments.He observed reagent probe aspiration issues and replaced the liquid-level detection (lld) board and parts to the reagent flow path.He verified the module's performance with qcs and precision checks.Cobas 2: the calibration and qc were within specifications.The field service engineer (fse) inspected the module but did not find the specific cause of the event.He replaced the channel's black sipper and pinch valve tubing and checked the related parts.He verified the module's performance with mechanical and precision checks.The customer performed qc with acceptable results.The customer performed a 1:2 dilution of the patient samples.Product labeling states: "dilution - samples with 25-hydroxyvitamin d concentrations above the measuring range can be manually diluted with diluent universal or a suitable human serum with a low analyte concentration.The recommended dilution is 1:2.The concentration of the diluted sample must be = 40 ng/ml (= 100 nmol/l).After manual dilution, multiply the results by the dilution factor 2.The endogenous analyte concentration of the human serum used for dilution has to be taken into account." the investigation is ongoing.
Additional Manufacturer Narrative
The vit d total calibration signals for cobas 1 were slightly higher than the specified ranges.The vit d total qcs for cobas 1 and cobas 2 were within the specified ranges.There was no indication of a performance issue with the reagent because the qcs before the event were within the specified ranges and isolated non-reproducible results do not represent a general malfunction of the assay.The customer did not report any other issues after service.The investigation determined the service actions resolved the issue.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21525950
• Report Number: 1823260-2025-00631
• Device Sequence Number: 9619066
• Product Code: MRG
• UDI-Device Identifier: 07613336184615
• UDI-Public: 07613336184615
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 03/21/2025

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: 05/31/2025
• Device Catalogue Number: 09038078160
• Device Lot Number: 81427801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2025
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 03/21/2025
• 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 Age: 79 YR
• Patient Sex: Female
• Patient Weight: 93 KG