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

Model Number VITD TOTAL

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/23/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(6).

Event Description

The initial reporter stated they received discrepant results for two samples from the same patient tested with the elecsys vitamin d assay (vitd) and the elecsys vitamin d gen.2 assay (vitd2).Incorrect results for vitd and vitd2 were reported outside of the laboratory.This medwatch will apply to the vitd assay.Please refer to the medwatch with patient identifier (b)(6) for information related to vitd2.Refer to the attachment for all patient data.The samples were tested with vitd on the cobas 6000 e 601 module used at the customer site (e 601 #1).The samples were tested with vitd2 on a second e 601 analyzer (e 601 #2) used at a second site.The samples were also tested with vitd at a third site using an unknown roche analyzer.The e 601 analyzer used at the customer site (e 601 #1) is serial number (b)(4).The serial numbers of the other two analyzers were requested, but not provided.

Manufacturer Narrative

Refer to the attachment for updated information.Fields in yellow have been updated.The 216 nmol/l value in row 2 of the table is actually the final calculated value for the last (b)(6) 2019 measurement of sample 1 (108.2 nmol/l after x2 manual dilution).The serial numbers of the other two analyzers at the third site were provided as (b)(6).Medwatch fields a3 and b3 has been updated.The patient is a clinician and believed the vitd2 results to be clinically correct as she does not have the possibility of vitamin d toxicosis.- attachment: [pt-42560_pt-42561.Pdf].

Manufacturer Narrative

Based on the provided information and data, the observed differences can be explained as follows: vitd2 has low cross reactivity to vitamin d metabolites, compared to vitd.Therefore, cross reactivity of the sample to the vitd assay is possible.Different assay standardizations can contribute to a different recovery of higher concentrated samples.Vitamin d derivatives in the sample may be recognized by the vitd assay, but these same derivatives may have reduced recognition or may not be recognized with the vitd2 assay.

• Brand Name: ELECSYS VITAMIN D ASSAY
• Type of Device: VITAMIN D TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9546565
• MDR Text Key: 199260458
• Report Number: 1823260-2020-00028
• Device Sequence Number: 1
• Product Code: MRG
• Combination Product (y/n): N
• PMA/PMN Number: K113546
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: VITD TOTAL
• Device Catalogue Number: 05894913190
• Device Lot Number: 43548302
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1