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

Catalog Number	07028148190
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	11/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 8000 core unit serial number was (b)(6).The e801 analyzer serial number was not provided.The investigation is ongoing.
Event or Problem Description
The initial reporter complained of qc issues with a particular reagent lot for elecsys vitamin d total ii (vitamin d total ii) occurring since (b)(6) 2024.There was an allegation of a discrepant high result for 1 patient sample tested for vitamin d total ii on a cobas e801 analyzer.The initial result was 71.3 ng/ml.This result was reported outside of the laboratory where the doctor indicated the result did not match the patient¿s clinical condition.The sample was repeated on a different e801 analyzer with a result of 23.0 ng/ml.On (b)(6) 2024 the original sample was repeated on the e801 analyzer in question with a result of 20.2 ng/ml.
Additional Manufacturer Narrative
Calibration signals were acceptable.Qc data provided between 31-oct-2024 and 01-nov-2024 showed significant fluctuations.No qc data from the day of the event was provided.No relevant issues were observed in the alarm trace data.The customer used a coagulation time of 20 minutes.The clotting time for most serum tubes is 30-60 minutes.The customer used a fixed centrifugation.Swing-out rotor centrifugation is recommended.Images of the reagent kit were provided and showed partial agglutination of the magnetic beads.The issue was resolved by replacing the reagent kit.Based on the agglutination of the magnetic beads, the investigation determined the event was consistent with a reagent handling/storage issue.

• Brand Name: ELECSYS VITAMIN D TOTAL II
• 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: 20892389
• Report Number: 1823260-2024-03586
• Device Sequence Number: 8773076
• Product Code: MRG
• UDI-Device Identifier: 04015630940127
• UDI-Public: 04015630940127
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K162840
• 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): 02/06/2025

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: 06/30/2025
• Device Catalogue Number: 07028148190
• Device Lot Number: 801240
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2024
• Supplement Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 02/06/2025
• 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 Sex: Unknown