MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS FT4 REAGENT PACK; IN VITRO DIAGNOSTICS

Catalog Number 1387000

Device Problems High Test Results (2457); Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/15/2019

Event Type  malfunction  

Manufacturer Narrative

The assignable cause for the higher than expected vitros ft4 result and lower than expected vitros tsh result could not be determined with the information provided.The customer did not provide any qc fluid information, so it was not possible to make an appropriate assessment of the vitros reagent performance at the time of the event for either assay.Additionally, precision testing of the vitros system was not performed, therefore it cannot be confirmed that the instrument was operating as intended and unexpected instrument performance cannot be completely ruled out as contributing to the events.In addition, it was not possible to establish if either customer was following the sample collection device manufacturer¿s recommended centrifugation protocol; therefore, pre-analytical sample processing cannot be ruled out as a contributing factor.It is possible that cellular debris, due to poor sample preparation, was present in the affected samples, although this could not be confirmed.Furthermore, the sample was reported to be visibly icteric and the sample may have interfered with the vitros assays.No sample remained for investigative testing at the time the issue was reported.

Event Description

A customer reported a higher than expected vitros ft4 result and a lower than expected vitros tsh result obtained from a single patient sample (patient 1) when tested on a vitros eci immunodiagnostic system.Patient sample 1 vitros ft4 result of 66 pmol/l versus the expected result of 8.0 pmol/l patient sample 1 vitros tsh result of 0.153 miu/l versus the expected result of 0.4407 miu/l biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The vitros ft4 result was not reported to a physician and no action was taken based on the result.It was not known if the vitros tsh result was reported from the laboratory.However, ortho has not been made aware of any allegation of patient harm for the patient as a result of this event.This report is number one of two mdr's for this event.Two 3500a forms are being submitted for this event as two devices were involved.This report corresponds to ortho clinical diagnostics inc.(b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS FT4 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: 8538004
• MDR Text Key: 160603814
• Report Number: 3007111389-2019-00067
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: TS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• 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: 05/27/2019
• Device Catalogue Number: 1387000
• Device Lot Number: 4170
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1