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

Catalog Number 09038086190

Device Problem Low Test Results (2458)

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

Event Date 07/11/2023

Event Type  malfunction  

Manufacturer Narrative

The e801 analyzer serial number was (b)(6).Calibration was last performed on (b)(6) 2023 with acceptable results.No qc results were provided from the day of the event.Between (b)(6) 2023 and (b)(6) 2023 there were 7 sample quality-related alarms observed on the alarm trace data.The investigation is ongoing.

Event Description

The initial reporter complained of a discrepant low result for 1 patient sample tested for elecsys vitamin d total iii (vitamin d total iii) on a cobas e 801 analytical unit.The initial result from the e801 analyzer was 16.1 ng/ml.On (b)(6) 2023 the sample was repeated by an unspecified chemiluminescence method and the result was 28.2 ng/ml.This result was believed to be correct.On (b)(6) 2023 the repeat result from the e801 module was 18.8 ng/ml.

Manufacturer Narrative

Section d4, expiration date was updated.Qc was not run on the day of the event.Product labeling states: "controls for the various concentration ranges should be run individually at least once every 24 hours when the test is in use, once per cobas e pack, and following each calibration." qc run the day after the event was acceptable.A reagent issue is not suspected.No preanalytical handling issues were identified.The sample was requested for investigation but was not provided.Based on the information provided, a general reagent issue can be excluded.Assays from different manufacturers can generate different results.This relates to the overall setups of the assays, the antibodies used, differences in reference materials and the standardization methodology used.Since the sample was not available for investigation, the cause of the event could not be determined.The investigation did not identify a product problem.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg)
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250-0457
• MDR Report Key: 17468695
• MDR Text Key: 320602406
• Report Number: 1823260-2023-02529
• Device Sequence Number: 1
• Product Code: MRG
• UDI-Device Identifier: 07613336172650
• UDI-Public: 07613336172650
• 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: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 09038086190
• Device Lot Number: 701158
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female