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 Known Impact Or Consequence To Patient (2692)

Event Date 11/01/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that lower than expected vitros psa results were attained from two different patient samples using vitros immunodiagnostics products psa (psa) reagent in combination with a vitros 5600 integrated system.The results were lower then expected when compared to the results obtained from the same samples freshly drawn.A definitive assignable cause for the low results could not be determined.Based on historical quality control results, a vitros psa lot 3620 and 3640 performance issue is not a likely contributor to the event.Continual tracking and trending of complaints has not shown any existing signals that would point to a potential systemic issue with vitros immunodiagnostics products psa (psa) reagent lot 3620 or 3640.In addition, there is no indication of an instrument malfunction.However, a within run precision test was not run at the time of the event and therefore, an instrument issue cannot be definitively ruled out.Furthermore, pre-analytical sample processing cannot be ruled out as a contributing factor, as it was not possible to establish if the customer was following the sample collection device manufacturer¿s recommendation for sample centrifugation.It is possible that cellular debris, due to poor sample preparation, was present in the affected samples, although this could not be confirmed.Additionally, when samples are tested concurrently, reproducible results are obtained for both fresh and stored samples using both reagent lots.Only when fresh samples are compared to stored samples are biased results observed.Consequently, sample preparation and the handling and storage of the samples cannot be ruled out as a contributing factor to the event.

Event Description

A customer reported lower than expected patient sample results attained using vitros immunodiagnostics products psa (psa) reagent on a vitros 5600 integrated system.Patient sample 1 results of 29.5 and 28.3 ng/ml versus the expected result of 53.3 ng/ml.Patient sample 3 result of 2.27 ng/ml versus the expected result of 3.11 ng/ml.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The lower than expected vitros psa results were not reported from the laboratory.There have been no allegations of patient harm as a result of this event.This report is number 1 of 2 mdr¿s for this event.Two (2) 3500a forms are being submitted for this event as 2 devices were involved.(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: 8115468
• MDR Text Key: 129581995
• Report Number: 3007111389-2018-00183
• 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: 11/29/2018

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 Date: 02/06/2019
• Device Catalogue Number: 6801756
• Device Lot Number: 3640
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/02/2018
• Initial Date FDA Received: 11/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2018
• 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