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

Catalog Number 09038086190

Device Problems Low Test Results (2458); Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2023

Event Type  malfunction  

Event Description

There was an allegation of questionable vitamin d total g3 result from the cobas e 801 analytical unit.Sample 1 initial result was 13.0 ng/ml.On (b)(6) 2023, the repeat result on a cobas pure analyzer was 22.4 ng/ml.On (b)(6) 2023, the repeat result on the original analyzer with a new reagent pack was 17.9 ng/ml.Sample 2 initial result was 15.8 ng/ml.On (b)(6) 2023, the repeat result on a cobas pure analyzer was 24.7 ng/ml.

Manufacturer Narrative

The cobas e 801 analytical unit serial number was (b)(6).The investigation is ongoing.

Manufacturer Narrative

The field service engineer cleaned the reagent and sample probes, decontaminated the procell syringe, and adjusted the sample and reagent probes.He recalibrated the assay and performed a sample comparison and precision testing that was acceptable.The investigation did not identify a product problem.The cause of the event could not be determined.The comparability of the assay improved after the service actions.A general reagent issue was not evident.

• Brand Name: ELECSYS VITAMIN D TOTAL III
• Type of Device: 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: 18456203
• MDR Text Key: 332736615
• Report Number: 1823260-2024-00055
• Device Sequence Number: 1
• Product Code: MRG
• Combination Product (y/n): Y
• Reporter Country Code: BR
• PMA/PMN Number: K210901
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 09038086190
• Device Lot Number: 744661
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1