MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T4 REAGENT PACK; IN VITRO DIAGNOSTICS

Catalog Number 1387000

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that lower than expected vitros ft4 results were obtained using a vitros 5600 system when compared to the ft4 result obtained using free t4 equilibrium dialysis (edft4) the root cause of the lower than expected ft4 results is unknown.The historical vitros ft4 quality control results do not indicate an issue with vitros ft4 lot 4540.However, the performance of vitros ft4 lot 4180 or 4360 could not be assessed; therefore, a reagent issue could not be ruled out as a contributor of the events associated with patient 2 and patient 3.However, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros ft4 lot 4540, 4180 or 4360.Although the acceptable diagnostic precision test results indicate the vitros 5600 system is currently performing as expected, an analyzer related issue could not be ruled out for the events occurring in (b)(6) 2019, (b)(6) 2020, or (b)(6) 2020.The customer indicated the samples are all serum samples which were aliquoted after testing and frozen for transport.The samples are typically tested within 7 to 10 days at the reference laboratory.Therefore, sample handling is not a likely cause of the lower than expected ft4 results.(b)(4).

Event Description

The customer reported lower than expected vitros immunodiagnostics products free t4 (ft4) patient results using a vitros 5600 when compared to ft4 results obtained from a reference laboratory using a non-vitros free t4 equilibrium dialysis (edft4) method.Vitros ft4 lot 4180 ¿ 15 march 2019 patient 1, vitros ft4 result 0.7 ng/dl versus edft4 result 2.6 ng/dl.Vitros ft4 lot 4360 ¿ 4 february 2020 patient 2, vitros ft4 result 2.0 ng/dl versus edft4 result 3.0 ng/dl.Vitros ft4 lot 4540 - 8 october 2020 patient 3, vitros ft4 result 0.7 ng/dl versus edft4 result 2.7 ng/dl.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The lower than expected ft4 results were not reported outside of the laboratory and there was no allegation of patient harm as a result of the events.This report is number 2 of 3 mdr¿s for this event.Three (3) 3500a forms are being submitted for this event as three devices were involved.This report corresponds to ortho clinical diagnostics inc.Complaint numbers (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T4 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: joseph falvo ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 11019007
• MDR Text Key: 252297375
• Report Number: 3007111389-2020-00209
• Device Sequence Number: 1
• Product Code: CEC
• 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: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2020
• Device Catalogue Number: 1387000
• Device Lot Number: 4360
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2019
• 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