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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 07464215190
Device Problem Non Reproducible Results (4029)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/28/2019
Event Type  malfunction  
Manufacturer Narrative
The provided calibration and qc data was acceptable.The analyzer alarm trace contained many sample aspiration errors on the day of the event.The investigation is ongoing.This event occurred in (b)(6).
 
Event Description
The initial reporter received questionable vitamin d total g2 results for 27 patients from cobas 6000 e 601 module serial number (b)(4).Refer to the attachment to the medwatch for all patient data.The initial results were accompanied by data flags.The questionable results were reported outside of the laboratory.The repeat results were believed to be correct.The reagent expiration date was provided as "nov 2019".
 
Manufacturer Narrative
The data provided did not indicate a general reagent issue.The investigation did not identify a product problem.The cause of the event could not be determined.
 
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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 Key9349372
MDR Text Key214812512
Report Number1823260-2019-04139
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 12/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number07464215190
Device Lot Number391920
Was Device Available for Evaluation? Yes
Date Manufacturer Received10/31/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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