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

Catalog Number	09038086190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys vitamin d total iii results for approximately 70 patient samples on a cobas 8000 e 801 module.The following are three examples of discrepant results: patient 1: the initial result was 300 nmol/l with a data flag.The repeated result was 58.1 nmol/l.The doctor questioned the results and the customer noted patient 1's high total protein result prompting the rerun of the patient samples.Patient 2: the initial result was 86.3 nmol/l.The sample was repeated on (b)(6) 2025 and the result was 7.5 nmol/l with a data flag.Patient 3: the initial result was 300 nmol/l with a data flag.The repeated result was 178 nmol/l.The sample was repeated on (b)(6) 2025 and the result was 153 nmol/l.The samples were repeated after the physician questioned the initial results.
Additional Manufacturer Narrative
E1 initial reporter establishment name: (b)(6).The analyzer's serial number is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The calibration and qc were acceptable.A general reagent issue was excluded.A film on the sample surface was observed for one of the samples.The alarm trace showed several sample-related alarms ("sample short" and "sample foam detection") on the day of the event.The investigation determined the issue was consistent with one of the samples having a suspicious sample matrix (high protein) that led to contamination issues with the flow path.The investigation did not identify a product problem.

• 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: 21635833
• Report Number: 1823260-2025-00777
• Device Sequence Number: 9328932
• Product Code: MRG
• UDI-Device Identifier: 07613336172650
• UDI-Public: 07613336172650
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 06/02/2025

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: 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: 02/21/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 06/02/2025
• 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 Age: 70 YR
• Patient Sex: Female