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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 High Test Results (2457)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/25/2021
Event Type  malfunction  
Manufacturer Narrative
The investigation reviewed the customer's qc results.The investigation confirmed there were imprecision and low recoveries with qc results between the end of (b)(6) 2021 and the beginning of (b)(6) 2022.The patient's sample was requested for an investigation, but the customer confirmed no sample was available.For dilution testing, product labeling states, "samples with vitamin d (25-oh) concentrations above the measuring range can be manually diluted with diluent universal or a suitable human serum with a low analyte concentration.The recommended dilution is 1:2.The concentration of the diluted sample must be >30.0 ng/ml (>75.0 nmol/l).After manual dilution, multiply the results by the dilution factor 2.The endogenous analyte concentration of the human serum used for dilution has to be taken into account." the investigation is ongoing.
 
Event Description
The initial reporter received questionable elecsys vitamin d assay results for one patient tested on a cobas e411 disk.Prior to patient testing, the customer confirmed qc was within the acceptable range.The patient's elecsys vitamin d result was reported outside the laboratory.The patient's physician questioned the reported result as it did not match the patient's history.The customer performed dilution testing and sent the sample to a different laboratory for testing on a vidas analyzer.The patient's initial elecsys vitamin d result was ">70" ng/ml.The patient's repeat elecsys vitamin d result with a 1:3 dilution was 145.6 ng/ml with a data flag.The customer's vitamin d result interpretation was "possible toxicity." the patient's vidas vitamin d result was 86.7 ng/ml.The customer's vitamin d result interpretation was sufficient.The e411 serial number was (b)(4).
 
Manufacturer Narrative
The investigation reviewed the provided sample pre-analytic details, and the number of tube inversions was insufficient compared to the manufacturer's recommendations, and the sample clotting time was requested but not provided.The investigation reviewed the provided alarm trace and found sample short alarms on (b)(6) 2022.The alarm trace from the date of the event were requested but not provided.Based on the provided information, 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
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 Key13731427
MDR Text Key293080132
Report Number1823260-2022-00654
Device Sequence Number1
Product Code MRG
Combination Product (y/n)N
Reporter Country CodeID
PMA/PMN Number
K113546
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
Report Date 04/15/2022
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 Date09/30/2022
Device Model NumberVITD TOTAL
Device Catalogue Number05894913190
Device Lot Number57362001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/15/2022
Initial Date FDA Received03/11/2022
Supplement Dates Manufacturer Received03/24/2022
Supplement Dates FDA Received04/15/2022
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
Patient Age68 YR
Patient SexFemale
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