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

Catalog Number 1912997

Device Problem Incorrect Measurement (1383)

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

Event Date 07/21/2016

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected vitros tsh results were predicted from two samples from a single patient processed on a vitros eci immunodiagnostic system when compared to the tsh result obtained from a non-vitros method.A definitive assignable cause could not be identified.Based on historical qc data, a reagent performance issue could not be ruled out as a contributing factor.No instrument issue was identified as a contributing factor, however; a within-run precision test that would verify the performance of the vitros eci instrument was not processed, therefore, an instrument related issue cannot be entirely ruled out.Information regarding pre-analytical sample handling was not provided and therefore inappropriate sample preparation also cannot be ruled out as a contributing factor.

Event Description

The customer observed higher than expected vitros tsh results predicted from a two patient samples from a single patient processed on a vitros eci immunodiagnostic system when compared to a non-vitros method.Sample 1: 4.39 and 5.18 miu/l versus expected result of 1.58 miu/l.Sample 2: 3.25 miu/l versus expected result of 1.45 miu/l.Biased results of the direction and magnitude observed may lead to inappropriate physician action.It is not known if the higher than expected vitros tsh patient results were reported from the laboratory.There was no allegation of patient harm.(b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK
• Type of Device: IN-VITRO DIAGNOSTIC
• 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: 5964734
• MDR Text Key: 55631700
• Report Number: 3007111389-2016-00172
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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: 09/20/2016

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: 01/04/2017
• Device Catalogue Number: 1912997
• Device Lot Number: 5050
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/23/2016
• Initial Date FDA Received: 09/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1