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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 Problems Incorrect Measurement (1383); High Test Results (2457)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/14/2021
Event Type  malfunction  
Manufacturer Narrative
Na.
 
Event Description
The initial reporter stated they received questionable results for two patients sample tested with the elecsys vitamin d assay on a cobas e 411 immunoassay analyzer.The second patient sample was also tested on a cobas 6000 e 601 module and a cobas pro e 801 module.The first sample initially resulted in a vitamin d value of > 70 ng/ml when tested on the customer's e411 analyzer.The sample was repeated on an abbott analyzer, resulting in a value of 28.5 ng/ml.No incorrect results were reported outside of the laboratory for this sample.The second sample initially resulted in a vitamin d value of > 70 ng/ml when tested on the customer's e411 analyzer.The sample was repeated on an abbott analyzer resulting in a value that was much lower.The specific value measured with the abbott analyzer was not provided.The sample was sent to a second laboratory for testing on an e601 analyzer, resulting in a value of 49.64 ng/ml.The sample was also sent to a third laboratory for testing on an e801 analyzer where it resulted in values of 46.2 ng/ml and 53.3 ng/ml on (b)(6) 2021.It was asked, but it is not known if any incorrect results were reported outside of the laboratory for this sample.The customer believed the abbott values to be correct based on the clinical picture of the patients.The e411 analyzer serial number is (b)(4).Vitamin d reagent lot number 58937301, with an expiration date of 30-nov-2022 was used on this analyzer.The serial number of the e601 analyzer was requested, but not provided.Vitamin d reagent lot 589373, with an expiration date of 30-nov-2022 was used on this analyzer.The serial number of the e801 analyzer was requested, but not provided.Vitamin d reagent lot 568206 was used on this analyzer.The reagent expiration date was requested, but not provided.
 
Manufacturer Narrative
No incorrect results were reported outside of the laboratory for the second sample.The repeat measurements for the second sample were considered more reliable.
 
Manufacturer Narrative
The last calibration was performed on the e411 analyzer on 13-dec-2021 and signal counts were within expectations.The assay is calibrated regularly.Data for one level of control was provided for the e411 analyzer and was within range during the event.In the provided data, controls were out of range 2 times.Data for one level of control was provided for the e602 analyzer and was within range on (b)(6) 2021.Controls tested on the e 801 analyzer were within range on (b)(6) 2021.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 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 Key13096086
MDR Text Key290457843
Report Number1823260-2021-03894
Device Sequence Number1
Product Code MRG
Combination Product (y/n)N
Reporter Country CodeGR
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,Followup
Report Date 02/22/2022
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 Date11/30/2022
Device Model NumberVITD TOTAL
Device Catalogue Number05894913190
Device Lot Number58937301, 589373, 568206
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/15/2021
Initial Date FDA Received12/28/2021
Supplement Dates Manufacturer Received12/29/2021
01/28/2022
Supplement Dates FDA Received01/06/2022
02/22/2022
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
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