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

Catalog Number 1912997

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 06/25/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that lower than expected vitros tsh results were obtained from two different samples from the same patient when tested on a vitros 5600 integrated system using reagent lots 5900 and 5930 when compared to results obtained from a non-vitros system.The magnitude of bias of the vitros tsh results meets potential health and safety criteria and are reportable.Based on historical quality control results, a vitros tsh lot 5900 and lot 5930 performance issue is not a likely contributor to the events and the accuracy of the reagents has not been questioned by the customer.Additionally, there is also no indication of an instrument malfunction and unexpected instrument performance is not a likely contributor to the event.However, precision testing of the vitros system was not performed at the time of the events and it could not be confirmed that the instrument was operating as intended and therefore, unexpected instrument performance cannot be completely ruled out as contributing to the events.The most likely assignable cause for the lower than expected vitros tsh results obtained from the patient is an unknown sample specific interferent present in the patient samples themselves.The patient stated at the time of the complaint that they were in receipt of vitamin supplements but were not knowingly taking any supplement containing biotin.It is possible that the vitamin supplements the patient was taking contained biotin, but this information and the possible biotin dose remain unknown at the time of writing.The patient declined to provide any further information to the customer to aid investigation.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros tsh reagent lots 5900 and 5930.The lower than expected vitros tsh results were reported from the laboratory.However, no treatment was altered, initiated or stopped based on the lower than expected vitros results and ortho has not been made aware of any allegation of patient harm as a result of this event.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solutions center (tsc) to report lower than expected tsh patient sample results obtained from a single patient using vitros immunodiagnostic products tsh reagent on a vitros 5600 integrated system when compared to tsh results obtained using a non-vitros system at another laboratory.The date of the event was (b)(6) 2019.Patient 1 results of 0.05 and 0.03 miu/l (hyperthyroid) versus the expected result of euthyroid (vitros tsh euthyroid range - 0.465 ¿ 4.68 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 lower than expected vitros tsh results were reported from the laboratory.However, no treatment was altered, initiated or stopped based on the lower than expected vitros results and ortho has not been made aware of any allegation 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.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: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 9088759
• MDR Text Key: 219779053
• Report Number: 3007111389-2019-00146
• Device Sequence Number: 1
• Product Code: JLW
• 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: 09/19/2019

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: 02/12/2020
• Device Catalogue Number: 1912997
• Device Lot Number: 5900
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/30/2019
• Initial Date FDA Received: 09/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2019
• 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