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

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).

• Brand Name: ORTHO VITROS TOTAL TESTOSTERONE
• Type of Device: MULTI-ANALYTE CONTROLS, ALL KINDS (ASSAYED)
• Manufacturer (Section D): ORTHO CLINICAL DIAGNOSTICS
• MDR Report Key: 12370245
• MDR Text Key: 268471630
• Report Number: MW5103503
• Device Sequence Number: 1
• Product Code: JJY
• Number of Events Reported: 1
• 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 Received: 08/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other