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U.S. Department of Health and Human Services

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

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ROCHE DIAGNOSTICS ELECSYS VITAMIN D TOTAL III; VITAMIN D TEST SYSTEM Back to Search Results
Catalog Number 09038086190
Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457); Non Reproducible Results (4029)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/26/2024
Event Type  malfunction  
Manufacturer Narrative
The serial number of the e801 analyzer is (b)(6).Medwatch field e1 facility name - (b)(6) hospital.Calibration and controls were acceptable.The investigation is ongoing.
 
Event Description
The initial reporter stated they received discrepant results for four patient samples tested with elecsys vitamin d total iii on a cobas e 801 module.The first sample initially resulted in a vitamin d value of 81.7 ng/ml and it repeated as 35.2 ng/ml.The second sample initially resulted in a vitamin d value of 104 ng/ml on (b)(6) 2024.The sample was repeated three times on (b)(6) 2024, resulting in values of 38.2 ng/ml, 98.5 ng/ml, and 95.9 ng/ml.The reagent pack was changed and the sample was repeated on (b)(6) 2024, resulting in a value of 25.4 ng/ml.The third sample initially resulted in a vitamin d value of 50.4 ng/ml on (b)(6) 2024.The sample was repeated on (b)(6) 2024, resulting in a value of 37.1 ng/ml.The reagent pack was changed and the sample was repeated on (b)(6) 2024, resulting in a value of 26.9 ng/ml.The fourth sample initially resulted in a vitamin d value of 105 ng/ml on (b)(6) 2024.The sample was repeated twice on (b)(6) 2024, resulting in values of 18 ng/ml and 28.0 ng/ml.The reagent pack was changed and the sample was repeated on (b)(6) 2024, resulting in a value of 27.9 ng/ml.The values measured after the reagent pack change were reported outside of the laboratory as these agreed with the previous values of the patients.
 
Manufacturer Narrative
Calibration and controls were acceptable prior to the event.A general reagent issue could be ruled out as controls were acceptable.Upon review of the alarm trace, no relevant alarms were observed.Analyzer performance testing was within specifications.The field service engineer checked the mixer and probe position; these were acceptable.Precision studies were acceptable.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 III
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
sandhofer strasse 116
mannheim (baden-wurttemberg) 68305
GM   68305
Manufacturer Contact
amy nelson
9115 hague road
indianapolis, IN 46250
MDR Report Key18695350
MDR Text Key336514402
Report Number1823260-2024-00416
Device Sequence Number1
Product Code MRG
Combination Product (y/n)Y
Reporter Country CodeTW
PMA/PMN Number
K210901
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 Followup
Report Date 04/17/2024
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 Date05/31/2024
Device Catalogue Number09038086190
Device Lot Number744661
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/13/2024
Supplement Dates Manufacturer Received04/17/2024
Supplement Dates FDA Received04/17/2024
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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