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

Catalog Number 07464215160

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/04/2019

Event Type  malfunction  

Event Description

The customer received questionable elecsys vitamin d g2 assay results for one patient from cobas 6000 e 601 module serial number (b)(4).The initial result was > 100 ng/ml with a data flag.The customer repeated the same sample and the result was 60.77 ng/ml which was reported outside of the laboratory.The doctor questioned the result as the patient had a result from (b)(6) 2018 of 36.4 ng/ml.On (b)(6) 2019, the customer repeated the same sample and the results were 38.74 ng/ml and 37.63 ng/ml.These results were believed to be correct.There was no adverse event.Roche diagnostics has issued an urgent medical device correction for this issue, entitled "elecsys® vitamin d total ii assay ¿ non-reproducible false high results." this correction has been reported to fda.During the implementation of the elecsys vitamin d total ii assay on the modular analytics e 170 module, and cobas e 601 and 602 systems, there were reports of non-reproducible, false high results.These customer observations were made in comparisons of duplicate measurements during assay validation of elecsys vitamin d total ii assay or in method comparisons with elecsys vitamin d assay (i.E., during conversions), where the falsely elevated discrepant value did not fit the expected result.The observed elevated results reported with the elecsys vitamin d ii assay were not confirmed upon repeat testing of the affected samples.The observed findings: the first result is elevated, either above the upper end of the measuring range (>100 ng/ml or >250 nmol/ml), or within the measuring range; repeated results are significantly lower.Rare cases have been reported on the cobas e 411 analyzer and the cobas e 801 module.Roche is conducting investigations into the reported issue and has determined that the elecsys® vitamin d total ii assay is strongly affected by pre-analytical errors.The investigations have reproduced these findings when requirements for pre-analytical sample handling have not been met for plasma samples.Further investigations into the reported issue are ongoing.As a result, the pre-analytical sample quality and compliance to the tube manufacturer¿s specifications is very important to assure a high quality sample in order to minimize the risk of occurrence.Investigations are ongoing to determine the root cause of this issue.A workaround has been provided to customers.

Manufacturer Narrative

Evaluation result code and evaluation conclusion code have been updated.

• 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: 8350585
• MDR Text Key: 136526557
• Report Number: 1823260-2019-00682
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/27/2019

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: 03/31/2019
• Device Catalogue Number: 07464215160
• Device Lot Number: 340144
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/05/2019
• Initial Date FDA Received: 02/19/2019
• Supplement Dates Manufacturer Received: 02/05/2019
• Supplement Dates FDA Received: 03/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES 8008
• Patient Sequence Number: 1