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

Catalog Number 1912997

Device Problem No Apparent Adverse Event (3189)

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

Event Date 02/19/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that discordant vitros tsh results were obtained from a single patient sample when tested on a vitros 5600 integrated system and a vitros xt7600 integrated system using a vitros tsh reagent lot when compared to non-vitros tsh results.A definitive assignable cause for the discordant vitros tsh results could not be determined with the information provided.Based on historical quality control results, a vitros tsh performance issue is not a likely contributor to the event.There is also no indication of an instrument malfunction and unexpected instrument performance is not a likely contributor to the event.However, an instrument issue cannot be entirely ruled out as a contributing factor as precision testing to assess instrument performance was not performed by the customer at the time of the event.In addition, pre-analytical sample processing could not be ruled out as a contributing factor, as it was established the customer was not following the sample collection device manufactures recommendation for sample centrifugation.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.The most likely assignable cause for the discordant vitros tsh results for patient 1 is an unknown sample specific interferent present in the samples drawn from the patient in question.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros tsh reagent lot 6400.Email address for contact office is (b)(6).

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solutions center (tsc) to report discordant tsh patient sample results obtained from a single patient sample using a vitros immunodiagnostic products tsh reagent on a vitros 5600 integrated system and a vitros xt7600 integrated system when compared to non-vitros tsh results obtained for the same patient sample tested using two non-vitros systems.Patient 1 result of 9.2 and 9.52 miu/l versus the expected result of 74.7 miu/l.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The customer confirmed that the vitros tsh results were not reported from the laboratory to a physician and ortho has not been made aware of any 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 TSH 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: laurie o'riordan ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 11520023
• MDR Text Key: 267279527
• Report Number: 3007111389-2021-00038
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2021
• Device Catalogue Number: 1912997
• Device Lot Number: 6400
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2020
• 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