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

Catalog Number 07028148190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/12/2021

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The investigation is ongoing.

Event Description

The initial reporter received questionable elecsys vitamin d total ii results for one patient tested on a cobas 8000 e 801 module serial number (b)(4).The patient's elecsys vitamin d results were reported outside the laboratory.The patient's physician did not believe the initial result.The customer performed repeat testing with the same sample on a diasorin analyzer and an antellica analyzer.The customer also sent the patient's sample to another laboratory to be tested on an unknown analyzer with liquid chromatography with tandem mass spectrometry (lc-ms/ms) methodology.On (b)(6) 2021, the patient's elecsys vitamin d result was 84.1 ng/ml.On (b)(6) 2021, the patient's vitamin d result on a diasorin analyzer was 40 ng/ml.The patient's vitamin d result on an atellica analyzer was 54 ng/ml.The date of measurement was requested but not provided.On (b)(6) 2021, the patient's vitamin d result with lc-ms/ms methodology was 82 ng/ml.The patient's physician believed the vitamin d results from the diasorin analyzer and atellica analyzer were correct.

Manufacturer Narrative

The customer's qc results were acceptable.The customer's system alarm trace and sample pre-analytical details were requested but not provided.The investigation confirmed the exact specificity of the lc-ms/ms method used for testing was not provided but the lc-ms/ms result was comparable to the elecsys result obtained.Based on the available data, the investigation determined the observed discrepancy between the elecsys vitamin d total ii assay and the diasorin and antellica methods was the presence of a significant amount of a vitamin d derivate (c3-epi) in the sample.Per product labeling, the elecsys vitamin d assay does not have cross-reactivity to the vitamin d derivate (c3-epi) up to a concentration of "50 ng/ml." the investigation did not identify a product problem.

• Brand Name: ELECSYS VITAMIN D TOTAL II
• Type of Device: VITAMIN D TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11323165
• MDR Text Key: 255005841
• Report Number: 1823260-2021-00456
• Device Sequence Number: 1
• Product Code: MRG
• Combination Product (y/n): N
• PMA/PMN Number: K162840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 04/06/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 07028148190
• Device Lot Number: 484711
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/22/2021
• Initial Date FDA Received: 02/12/2021
• Supplement Dates Manufacturer Received: 01/22/2021
• Supplement Dates FDA Received: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1