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); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The calibration and qc were acceptable.The alarm trace showed several "sample foam detection" alarms on the day of the event.The agitation paddle adjustment was checked and was acceptable.A general reagent issue was excluded.Based on the information provided, the investigation did not identify a product problem.The cause of the event could not be determined.
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys vitamin d total iii results for 1 patient sample on a cobas 8000 e 801 module.The initial result was 207 nmol/l.The repeated result was 48.7 nmol/l.Additional results were provided from (b)(6) 2024.It is unknown if the results were from the same patient sample.The additional vitamin d results were: 83.9 nmol/l, 81.8 nmol/l, 82.4 nmol/l, 83.9 nmol/l, 84.2 nmol/l, 81.7 nmol/l, 79.0 nmol/l, 80.4 nmol/l, and 184 nmol/l.The patient is known to have a vitamin d result of approximately 60 nmol/l or 80 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 20005210
• Report Number: 1823260-2024-02393
• Device Sequence Number: 20673089
• Product Code: MRG
• UDI-Device Identifier: 07613336172650
• UDI-Public: 07613336172650
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• 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): 09/16/2024

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: 78907300
• 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: 07/23/2024
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 08/20/2024
• Supplement Report FDA Received Date: 09/16/2024
• 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: 72 YR
• Patient Sex: Male