MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK; IN VITRO DIAGNOSTICS

Catalog Number 6801756

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/29/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that lower than expected vitros psa results were attained from a single patient sample using two different vitros immunodiagnostic products psa reagent (psa) lots on two different vitros 5600 integrated systems during a reagent lot to lot correlation.The most likely assignable cause of the event is sample degradation between the original testing date ((b)(6) 2019) and the correlation testing date ((b)(6) 2019).Additional patient samples that were tested within 24 hours on both lots showed acceptable correlation.Based on historical quality control results, a vitros psa lot 3670 performance issue is not a likely contributor to the event.There was no historical quality control data for lot 3690 as it was a new lot being put into use at the time of the event.Additionally, ongoing tracking and trending of complaint data has not identified any signals to suggest a systemic quality issue with vitros psa lots 3690 or 3670.Although the customer did not perform precision testing the selling control performance observed on the instruments indicates that the performance of the vitros 5600 integrated systems was not a likely contributing factor to this event.In addition, the customer is using an engen laboratory automation system, therefore, sample processing is not a likely contributing factor.Furthermore, the customer is satisfied with both the instrument and reagent lot performance and agrees the likely cause of the lower than expected results is degradation of the patient sample.

Event Description

A customer reported lower than expected vitros psa (prostate specific antigen) patient sample results obtained using vitros immunodiagnostic products psa reagent (psa) in combination with two different vitros 5600 integrated systems.Patient sample results of 27.6 ng/ml (lot 3690, analyzer 56002576 on (b)(6) 2019) and 28.9 ng/ml (lot 3670, analyzer 56002577 on (b)(6) 2019) versus an expected result of 43.2 ng/ml (lot 3670, analyzer 56002576 on (b)(6) 2019).Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The lower than expected vitros psa patient sample results were not reported from the laboratory as they were attained during reagent lot to lot comparison testing.There was no allegation of patient harm as a result of this event.This report is number 2 of 2 mdr¿s for this event.Two (2) 3500a forms are being submitted for this event as 2 devices were involved.This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK
• Type of Device: IN VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO CLINICAL DIAGNOSTICS; felindre meadows; pencoed; bridgend, wales CF35 5PZ; UK CF35 5PZ
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 8536707
• MDR Text Key: 161845033
• Report Number: 3007111389-2019-00065
• Device Sequence Number: 1
• Product Code: LTJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/07/2019
• Device Catalogue Number: 6801756
• Device Lot Number: 3670
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1