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 Patient Involvement (2645)

Event Date 03/17/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that lower than expected vitros ft4 quality control results were obtained when the customer was running non-vitros (seromorm) quality control fluids on a vitros 5600 integrated system.A definitive cause of the lower than expected vitros ft4 results was not established.A transient instrument problem on the day of the event cannot be ruled out as a contributor.Following the event, the customer performed a deep clean on the microwell incubator and replaced the microwell proboscis.Quality control results since customer actions were within acceptable guidelines.A diagnostic precision test conducted following microwell incubator cleaning and microwell proboscis replacement was within acceptable guidelines, indicated acceptable instrument performance.A vitros ft4 lot 4400 reagent issue is an unlikely contributor to the event as quality control results prior to the event and following the event were within acceptable guidelines.Additionally, ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros ft4 lot 4400.An issue with the seromorm quality control fluids is a possible contributor to the event, as vitros ft3 and vitros vitamin d results using the same quality control fluids were also unexpected.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solutions center (tsc) to report lower than expected quality control results from a non-vitros (seromorm) quality control fluid when tested using vitros ft4 reagent lot 4400 on a vitros 5600 integrated system.Seromorm l2 results of 23.099 and 22.040 pmol/l versus the expected result of 32.92 pmol/l 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 ft4 results were obtained from a non-patient fluid.Ortho was not made aware of any erroneous patient sample results that were obtained or reported from the laboratory and there was no allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc.Complaint number (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: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 9942616
• MDR Text Key: 240345224
• Report Number: 3007111389-2020-00038
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 04/09/2020

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: 09/08/2020
• Device Catalogue Number: 1387000
• Device Lot Number: 4400
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/17/2020
• Initial Date FDA Received: 04/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2020
• 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