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 Consequences Or Impact To Patient (2199)

Event Date 04/08/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that lower than expected vitros thyroid stimulating hormone (tsh) results were obtained from two different patient samples processed using vitros tsh reagent on a vitros 5600 integrated system.The results were deemed lower than expected when compared to tsh results obtained from an external laboratory electrochemiluminescence test method.For patient sample 1, the lower than expected vitros tsh results were caused by biotin interference in the sample as it was found that the patient was taking a daily 10mg biotin supplement.In (b)(6) 2018, ortho issued a customer communication to alert customers that biased results may occur for specific vitros immunodiagnostic products (microwell assays) at biotin concentrations which are lower than indicated in the current instructions for use (ifu).For the vitros tsh assay, a negative bias may be observed (= 10% bias) in samples with a biotin concentration of 5 ng/ml (0.5 ug/dl).Therefore, a sample interferent that affects the vitros tsh assay was the likely assignable cause of the event for patient sample 1.For patient sample 5, the difference between results is likely due to the different testing methods as the external testing facility utilizes an electrochemiluminescence testing method while vitros tsh is a chemiluminescence based assay and the two different methods can give different results for the same samples.Based on historical quality control results a vitros tsh reagent lot 5855 performance issue is not a likely contributor to the event.Additionally, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros tsh reagent lot 5855.The customer performed within run precision testing using a vitros total thyroid control and two low dose patient samples.All testing yielded results that were within acceptable guidelines indicating the vitros 5600 integrated system was performing as expected and therefore, an instrument issue is not a likely contributing factor to this event.

Event Description

A customer reported multiple vitros thyroid stimulating hormone (tsh) patient sample results that did not correlate when compared to a different, external laboratory test method (electrochemiluminescence testing).The patient samples were processed using vitros tsh reagent in combination with a vitros 5600 integrated system.Patient sample 1 results of 0.053, 0.089, 0.069, 0.074, 0.077, 0.091 miu/ml versus a true result of 1.480 miu/ml patient sample 5 results of <0.015 miu/ml (5 replicates) versus a true result of 0.07 miu/ml.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The initial vitros result for patient sample 1 of 0.053 miu /ml was questioned by a physician who requested comparison testing to be carried out.No patient treatment has been altered based on the observed results.There was no allegation of patient harm as a result of this event.This report is number 2 of 2 mdr¿s for this event.Two (2) 3500a forms are being submitted for this event as 2 devices were involved.(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: 8579739
• MDR Text Key: 203840711
• Report Number: 3007111389-2019-00077
• 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: 05/03/2019

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: 10/15/2019
• Device Catalogue Number: 1912997
• Device Lot Number: 5855
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/08/2019
• Initial Date FDA Received: 05/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2019
• 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