• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ROCHE DIAGNOSTICS ELECSYS VITAMIN D TOTAL II; VITAMIN D TEST SYSTEM Back to Search Results
Catalog Number 07464215190
Device Problem High Test Results (2457)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/19/2019
Event Type  malfunction  
Manufacturer Narrative
This event occurred in (b)(6).
 
Event Description
The customer stated that they received erroneous results for four patient samples tested with the elecsys vitamin d total gen.2 assay on a cobas 6000 e 601 module between (b)(6) 2019.Of the four samples, one sample had an erroneous result which is reportable as a malfunction.The erroneous result was not reported outside of the laboratory.This sample initially resulted with a vitamin d value of 121.3 nmol/l and repeated as 30.01 nmol/l.The repeat result was believed to be correct.No adverse events were alleged to have occurred with the patient.The e 601 analyzer serial number is (b)(4).
 
Manufacturer Narrative
The qc data was within specified ranges.The alarm trace shows several sample-associated alarms.Improper pre-analytical steps including improper centrifugation were detected in the customer¿s sample handling.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.A workaround has been provided to customers.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key8320881
MDR Text Key135720078
Report Number1823260-2019-00524
Device Sequence Number1
Product Code MRG
Combination Product (y/n)N
PMA/PMN Number
K113546
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 03/20/2019
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 Date07/31/2019
Device Catalogue Number07464215190
Device Lot Number36669601
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 01/23/2019
Initial Date FDA Received02/08/2019
Supplement Dates Manufacturer Received01/23/2019
Supplement Dates FDA Received03/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-