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U.S. Department of Health and Human Services

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

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ROCHE DIAGNOSTICS ELECSYS VITAMIN D ASSAY; VITAMIN D TEST SYSTEM Back to Search Results
Model Number VITD TOTAL
Device Problem Low Test Results (2458)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/27/2019
Event Type  malfunction  
Manufacturer Narrative
This event occurred in (b)(6).
 
Event Description
The initial reporter complained of discrepant results for 1 patient tested for vitamin d total (vitamin d) and elecsys vitamin d total ii (vitamin d ii) on a cobas 8000 e 602 module and a cobas e801 module.This medwatch will cover vitamin d.Refer to medwatch with patient identifier (b)(6) for information on the vitamin d ii results.The initial vitamin d ii result from the e801 module was 35.9 ng/ml.The sample was repeated using vitamin d on the e602 module and the result was 3.00 ng/ml.The customer re-centrifuged the sample and repeated it on the e602 module with a result of 6.52 ng/ml.The customer performed a 1:2 dilution and repeated the sample on the e602 module with a result of 26.7 ng/ml.The customer reported the vitamin d ii result of 35.9 ng/ml outside of the laboratory.It is not clear which results the customer believes to be correct.A new sample was obtained from the patient on (b)(6) 2019 and the vitamin d ii result from the e801 module was 66.5 ng/ml.The customer attempted to run this sample on the e602 module, however, an alarm message was received with no result.The customer observed a clot at the sipper probe.There was no allegation that an adverse event occurred.The e602 module serial number was (b)(4).The e801 module serial number was not provided.
 
Manufacturer Narrative
The customer testing a sample from the patient by liquid chromatography-tandem mass spectrometry (lcms/ms) and the vitamin d ii result was 21.67 ng/ml.The investigation tested a sample from the patient on an e801 module.The investigation was able to reproduce the customer's vitamin d and vitamin d ii results.The investigation tested this patient sample by the lcms/ms method and received a vitamin d ii result (18.9 ng/ml) that was comparable to the customer's lcms/ms result of 21.67 ng/ml.Investigations are ongoing.
 
Manufacturer Narrative
The investigation determined that the difference in results between vitamin d and vitamin d ii assays are related to an unknown issue with the patient sample; the patient is a cancer patient with an unknown blood composition.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 ASSAY
Type of Device
VITAMIN D TEST SYSTEM
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
MDR Report Key8523509
MDR Text Key142354730
Report Number1823260-2019-01524
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 07/22/2019
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 Date08/31/2019
Device Model NumberVITD TOTAL
Device Catalogue Number05894913190
Device Lot Number35655502
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 03/27/2019
Initial Date FDA Received04/17/2019
Supplement Dates Manufacturer Received03/27/2019
03/27/2019
Supplement Dates FDA Received06/07/2019
07/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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