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); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's cobas e 801 analytical unit is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys vitamin d total iii results from patient samples tested on the cobas e 801 analytical unit.The following examples of discrepant results were reported: sample 1 on (b)(6) 2025: the initial result from the analyzer was 161 ng/ml.On (b)(6) 2025: the repeat result from another laboratory that uses the liquid chromatography-tandem mass spectrometry (lc-ms/ms) method was 52 ng/ml (no detectable vitd2).Sample 2 on (b)(6) 2025: the initial result from the analyzer was 223 ng/ml.On (b)(6) 2025: the repeat result from the other laboratory's lc-ms/ms method was 80 ng/ml (no detectable vitd2).The initial results did not match the patients' clinic pictures, prompting the patient sample reruns.The repeat results were deemed correct.Sample 3 on (b)(6) 2025: the initial result of the initial patient sample from the analyzer was 113 ng/ml.This result was questioned, prompting the patient sample rerun.The first repeat result from a second e 801 analyzer was 118 ng/ml with a data flag.The second repeat result from a third e 801 analyzer was 130 ng/ml with a data flag.On (b)(6) 2025: the result of another patient sample from the other laboratory's lc-ms/ms method was "48 ng/ml for d3 (non-detectable levels for d2)".
Additional Manufacturer Narrative
Medwatch field d4 expiration date was updated.The patient samples are not available for investigation.The calibration and qcs were within the specified ranges.The patient samples were in microtainer tubes and centrifuged for 5 minutes; the recommended centrifugation time is 5 minutes.The alarm trace contained multiple sample probe abnormal aspiration, sample foam detection, and sample short alarms.These are indicators of possible poor sample quality.The field service engineer (fse) and the field applications specialist (fas) investigated the event and noted that the patient samples sent to the other laboratory were from different blood collections.The fse verified that the analyzer was performing according to specifications.The investigation did not identify a product problem.The cause of the event could not be determined.
Additional Manufacturer Narrative
In the initial medwatch, h11 additional narrative should have been: "the patient samples were in microtainer tubes and centrifuged for 3 minutes; the recommended centrifugation time is 5 minutes." instead of: "the patient samples were in microtainer tubes and centrifuged for 5 minutes; the recommended centrifugation time is 5 minutes.".

• 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: 21526295
• Report Number: 1823260-2025-00632
• Device Sequence Number: 8340007
• Product Code: MRG
• UDI-Device Identifier: 07613336172650
• UDI-Public: 07613336172650
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 05/16/2025

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: 09038086190
• Device Lot Number: 820298
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/07/2025
• Supplement Date Received by Manufacturer: 04/30/2025; 04/30/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 05/15/2025; 05/16/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: VITAMIN D3 SUPPLEMENTS (ALL PATIENTS)
• Patient Sex: Unknown