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

Model Number E601

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2018

Event Type  malfunction  

Manufacturer Narrative

The event occurred in (b)(6).

Event Description

The customer complained of questionable high elecsys vitamin d assay results for 17 patients tested on a cobas 6000 e 601 module.The customer did not provide the specific vitamin d results and only stated the initial results were >250 nmol/l and when repeated the results would be normal, around 30 - 50 nmol/l.The erroneous results were not reported outside of the laboratory.There was no allegation of an adverse event.The vitamin d reagent lot information was requested but was not provided.The investigation is currently ongoing.

Manufacturer Narrative

The customer provided further clarification.Of the 17 patient's with high vitamin d results, all the initial results would be > 250 nmol/l and the rerun results would be in the range of 20 - 110 nmol/l.The vitamin d reagent lot was 326412 with an expiration date that was not provided.All the patient samples were processed by an automated preanalytical system.

Manufacturer Narrative

The expiration date of the reagent used is 31-jan-2019.The cause of the event could not be determined.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.

Manufacturer Narrative

After further investigation it was determined that serum samples are not affected by the recall.Correction/removal report number has been updated.Brand name thru other #, mfr site information were 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: 8216684
• MDR Text Key: 132088138
• Report Number: 1823260-2019-00040
• 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,Followup
• Report Date: 07/11/2019

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: 01/31/2019
• Device Model Number: E601
• Device Catalogue Number: 07464215190
• Device Lot Number: 326412
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/20/2018
• Initial Date FDA Received: 01/04/2019
• Supplement Dates Manufacturer Received: 12/20/2018; 12/20/2018; 12/20/2018
• Supplement Dates FDA Received: 01/24/2019; 03/08/2019; 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES 8008
• Patient Sequence Number: 1