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

Catalog Number	09038086190
Medical Device Problem Codes	Contamination (1120); Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys vitamin d total iii results from the cobas e 801 analytical unit for two patients.Patient 1's initial result was 6.18 ng/ml.The repeat result on (b)(6) 2025 was 16.9 ng/ml.Patient 2's initial result was 11.1 ng/ml.The repeat result on (b)(6) 2025 was 20.7 ng/ml.The samples were repeated when the customer noticed that multiple results were low.
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number is (b)(6).The customer reported experiencing inconsistent calibration signals but were still in the expected range.The qc was within range before the sample measurement on (b)(6) 2025.The qc was not in range on (b)(6) 2025, before the repeat measurement.The investigation is ongoing.
Additional Manufacturer Narrative
Per product labeling, "6.00-120 ng/ml or 15.0-300 nmol/l (defined by the limit of quantitation (loq) and the maximum of the master curve).Values below the limit of quantitation are reported as < 6.00 ng/ml (< 15.0 nmol/l).Values above the measuring range are reported as > 120 ng/ml (> 300 nmol/l) or up to 240 ng/ml (600 nmol/l) for 2-fold diluted samples." "lower limits of measurement.Limit of blank, limit of detection and limit of quantitation.Limit of blank = 2.0 ng/ml (5.0 nmol/l).Limit of detection = 3.0 ng/ml (7.5 nmol/l).Limit of quantitation = 6.0 ng/ml (15.0 nmol/l)".In general, the results measured by the customer are in the low measuring range.In the low measuring range, slight imprecision could lead to discrepancies between the modules.The imprecision is possibly caused by contamination or issues during the pre-analytical preparation.The investigation determined that a general reagent or analyzer problem was not present because the qc prior to the event was within ranges.The investigation also determined that there was dust present on the instrument surface, and there was crystallization at the pro cell and clean cell nozzles.

• 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 23741510
• Report Number: 1823260-2025-04984
• Device Sequence Number: 8420773
• Product Code: MRG
• UDI-Device Identifier: 07613336172650
• UDI-Public: 07613336172650
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 12/18/2025

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 Catalogue Number: 09038086190
• Device Lot Number: 868972
• 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: 11/10/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 12/18/2025
• 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: 55 YR
• Patient Sex: Male