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

Catalog Number	09038086190
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample from the patient with hyperglobulinemia had a total protein value of 128.6 g/l and an albumin value of 37.3 g/l.The investigation determined the issue is consistent with a sample quality issue contributing to the non-reproducible results.Samples exceeding the thresholds for igg, iga, igm, and albumin may not be suitable for measurement with the vitamin d assay.Per product labeling, there were no interferences up to the listed concentrations of the following endogenous substances: serum albumin concentration up to <= 7 g/dl.Igg concentration up to <= 7 g/dl.Iga concentration up to <= 1.3 g/dl.Igm concentration up to <= 1 g/dl.
Additional Manufacturer Narrative
The serial number of the e 801 analyzer is (b)(6).The field service engineer flushed the tubing and all subsequent quality control and patient sample results turned normal.A review of alarm trace data showed some sample related alarms (sample clot, sample foam, short sample).On (b)(6) 2025, a clot alarm and short sample alarm occurred.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for 9 patient samples tested with elecsys vitamin d total iii on a cobas e 801 analytical unit.The customer noted that due to a sample from a patient with hyperglobulinemia, a blockage occurred in the sipper probe tubing.The customer performed an experiment with the sample noting that the sample rapidly formed a jelly-like clot upon addition of vitamin d reagent.No questionable results were reported outside of the laboratory.The sample from the patient with hyperglobulinemia initially resulted in a vitamin d value of > 300 nmol/l.This sample was repeated twice, resulting in values of > 320 nmol/l and < 7.5 nmol/l.The sample was treated with polyethylene glycol and tested, resulting in a value of 125 nmol/l.The second sample initially resulted in a vitamin d value of > 300 nmol/l and it repeated as 48 nmol/l.The third sample initially resulted in a vitamin d value of 237 nmol/l and it repeated as 40.7 nmol/l.The fourth sample initially resulted in a vitamin d value of 236 nmol/l and it repeated as 57.6 nmol/l.The fifth sample initially resulted in a vitamin d value of 107 nmol/l and it repeated as 40.2 nmol/l.The sixth sample initially resulted in a vitamin d value of 163 nmol/l and it repeated as 26.8 nmol/l.The seventh sample initially resulted in a vitamin d value of 142 nmol/l and it repeated as 21.7 nmol/l.The eighth sample initially resulted in a vitamin d value of 198 nmol/l and it repeated as 48 nmol/l.The ninth sample initially resulted in a vitamin d value of 164 nmol/l and it repeated as 37 nmol/l.

• 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: 22796425
• Report Number: 1823260-2025-02475
• Device Sequence Number: 8286707
• Product Code: MRG
• UDI-Device Identifier: 07613336172650
• UDI-Public: 07613336172650
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 09/02/2025

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: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2025
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 09/02/2025
• 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