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

Catalog Number 09038078190

Device Problems High Test Results (2457); High Readings (2459); Low Readings (2460)

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

Event Date 02/03/2022

Event Type  malfunction  

Event Description

The initial reporter stated they have started using the elecsys vitamin d gen.3 assay (vitd g3) on their cobas 8000 e 602 module.After switching to this reagent from the elecsys vitamin d gen.2 assay (vitd g2), the customer noticed a negative shift in their third party controls and a positive shift in roche controls and proficiency samples.Patient samples were tested using both assays and a positive shift was seen in patient samples tested with vitd g3.Data was provided for six patient samples which had result discrepancies between the vitd g2 and vitd g3 assays.It was asked, but it is not known if any incorrect results were reported outside of the laboratory.This medwatch will apply to the vitd g3 assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the vitd g2 assay.The serial number of the e 602 analyzer is (b)(4).

Manufacturer Narrative

Of the provided quality control data, roche controls tested with the vitd g3 assay were within range.Third party control recovery for the vitd g3 assay was also provided and higher imprecision could be seen on the lowest control level.Based on the provided control data, there was no indication of a general reagent issue.The investigation could not identify a product problem.The cause of the event could not be determined.

• 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) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13770066
• MDR Text Key: 296407708
• Report Number: 1823260-2022-00709
• Device Sequence Number: 1
• Product Code: MRG
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Followup
• Report Date: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09038078190
• Device Lot Number: 557617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2022
• 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