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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 07028148190
Device Problems High Test Results (2457); Low Test Results (2458)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/04/2021
Event Type  malfunction  
Manufacturer Narrative
Na.
 
Event Description
The initial reporter stated they received discrepant results for two patient samples tested with the elecsys vitamin d total gen.2 assay on a cobas 8000 e 602 module.It was asked, but it is not known if any incorrect results were reported outside of the laboratory.No units of measure were provided.The samples were initially tested using the vitamin d gen.2 assay and were frozen after measurement.The samples were then thawed to use as part of a validation study for the vitamin d gen.3 assay and were repeated using both the gen.2 and gen.3 assays.The measurements performed with the frozen/thawed sample were lower compared to the initial measurements.The vitamin d gen.3 assay or similar device is not cleared or approved for use in the united states.The first sample initially resulted in a vitamin d gen.2 value of 128 and then the sample was frozen.The sample was thawed and repeated using the gen.2 assay, resulting in a values of 91.6.The thawed sample was repeated using the gen.2 assay on a second analyzer, resulting as 78.6.The thawed sample was repeated using the gen.3 assay, resulting in a value of 83.9.The second sample initially resulted in a vitamin d gen.2 value of 157 and then the sample was frozen.The sample thawed and repeated using the gen.2 assay on a second analyzer, resulting in a value of 95.1.The thawed sample was repeated using the gen.3 assay, resulting in a value of 91.2.The e 801 analyzer serial number is (b)(4).
 
Manufacturer Narrative
The units of measure used for the vitamin d assays are ng/ml.
 
Manufacturer Narrative
The first sample was initially tested on (b)(6) 2021 and the second sample was initially tested on (b)(6) 2021.The customer confirmed they did not freeze the samples in question.The samples are stored on one module of the pre-analytics system for 2 hours after measurement and then they go to a second module for storage at 2-8 degrees celsius.Storage occurred overnight at 2-8 degrees celsius.Samples were repeated the following day.Calibration signals from the complained analyzer were within expected values.Calibration values from the second analyzer (e 801 serial number (b)(6)) were lower than expected.Quality controls were within range on the dates of the event.A general reagent issue could be excluded.Upon review of the alarm trace, no relevant alarms were observed.The investigation could 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
Manufacturer (Section G)
ROCHE DIAGNOSTICS GMBH
sandhoferstrasse 116
na
mannheim (baden-wurttemberg) 68305
GM   68305
Manufacturer Contact
michael leslie
9115 hague road
na
indianapolis, IN 46250
3175214343
MDR Report Key12422624
MDR Text Key273009554
Report Number1823260-2021-02591
Device Sequence Number1
Product Code MRG
UDI-Device Identifier04015630940127
UDI-Public04015630940127
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K162840
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 12/13/2021
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 Catalogue Number07028148190
Device Lot NumberASKU
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/17/2021
Initial Date FDA Received09/03/2021
Supplement Dates Manufacturer Received09/20/2021
11/22/2021
Supplement Dates FDA Received09/20/2021
12/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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