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U.S. Department of Health and Human Services

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

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ROCHE DIAGNOSTICS ELECSYS VITAMIN D TOTAL II; VITAMIN D TEST SYSTEM Back to Search Results
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.
 
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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 Key8350585
MDR Text Key136526557
Report Number1823260-2019-00682
Device Sequence Number1
Product Code MRG
Combination Product (y/n)N
PMA/PMN Number
K162840
Number of Events Reported1
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 Date03/31/2019
Device Catalogue Number07464215160
Device Lot Number340144
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/05/2019
Initial Date FDA Received02/19/2019
Supplement Dates Manufacturer Received02/05/2019
Supplement Dates FDA Received03/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberRES 8008
Patient Sequence Number1
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