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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHO CLINICAL DIAGNOSTICS ORTHO VITROS TOTAL TESTOSTERONE MULTI-ANALYTE CONTROLS, ALL KINDS (ASSAYED)

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ORTHO CLINICAL DIAGNOSTICS ORTHO VITROS TOTAL TESTOSTERONE MULTI-ANALYTE CONTROLS, ALL KINDS (ASSAYED) Back to Search Results
Device Problem High Test Results (2457)
Patient Problem Insufficient Information (4580)
Event Date 08/17/2021
Event Type  malfunction  
Event Description
Delayed turn around time/ref; we have issue with ortho vitros testosterone and estradiol assay. The results on some patient are running really higher. Per feedback from the provider, the patient were taking dim supplement. It is not on the list of supplements on their interference list for the assay. We tried calling the vitros customer support. We even did some study using blocking tubes for ruling out heterophile antibody and still the sample were running higher. Analytic errors were all ruled out (qc, calibration, instruments performance was good). We know there is an interferences with the assay but not sure what causing it. We send the labs to the reference lab for those test. They were all within the expected ranges. We are no longer running the test on vitros. We switched to siemens atelica platform. I just wanted to let fda know about the issue that way we can start troubleshooting on what may be the other reason causing this issues. The results on some patient are running really higher on female and some patients, we noticed estradiol being upper 1500 pg/ml. Solaris diagnostics. Fda safety report id # (b)(4).
 
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Brand NameORTHO VITROS TOTAL TESTOSTERONE
Type of DeviceMULTI-ANALYTE CONTROLS, ALL KINDS (ASSAYED)
Manufacturer (Section D)
ORTHO CLINICAL DIAGNOSTICS
MDR Report Key12370245
MDR Text Key268471630
Report NumberMW5103503
Device Sequence Number1
Product Code JJY
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 08/25/2021 Patient Sequence Number: 1
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