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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 ASKU
Device Problem Non Reproducible Results (4029)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/13/2018
Event Type  malfunction  
Manufacturer Narrative
This event occurred in (b)(6).
 
Event Description
The initial reporter stated that they received an erroneous result for one patient sample tested with the elecsys vitamin d total gen.2 assay on a cobas 6000 e 601 module.It was asked, but it is not known if an erroneous result was reported outside of the laboratory.The sample initially resulted with a vitamin d value of > 250 nmol/l.The sample was repeated twice, resulting with values of 56.3 nmol/l and 82.55 nmol/l.No adverse events were alleged to have occurred with the patient.The e 601 analyzer serial number was (b)(4).
 
Manufacturer Narrative
The investigation did not identify a product problem.The cause of the event could not be determined.
 
Manufacturer Narrative
After further investigation it was determined that serum samples are not affected by the recall.Correction,removal report number has 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 Key8408351
MDR Text Key138533877
Report Number1823260-2019-00993
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,Followup
Report Date 07/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberASKU
Device Lot NumberASKU
Was Device Available for Evaluation? Yes
Date Manufacturer Received02/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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