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

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 12/21/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that lower than expected vitros tsh results were obtained from a single cap linearity sample ln5-14, tested on a vitros 5600 integrated system.A definitive assignable cause for the lower than expected vitros tsh cap linearity results could not be determined.Based on historical quality control results, a vitros tsh lot 5550 performance issue is not a likely contributor to the event.Follow up testing which included a dilution study with a patient sample with a tsh level >100miu/ml, and testing of vitros tsh range verifiers demonstrated vitros tsh lot 5550 is performing as expected.While a vitros tsh within-run precision test met performance guidelines, an instrument issue cannot be completely ruled out as several weeks had elapsed between the time of the event and the precision test.In addition, an interaction with the cap sample fluid matrix cannot be ruled out.A definitive assignable cause for the event could not be determined.

Event Description

A customer obtained lower than expected vitros tsh results from a (b)(4) linearity sample tested on a vitros 5600 integrated system.Cap sample ln5-14 results of 43.1 and 43.2 miu/l vs.The expected result of 63.0312 miu/l biased results of the direction and magnitude observed may lead to inappropriate physician action.The lower than expected vitros tsh results were generated from non-patient fluid and the customer did not give any indication that patient results had been affected, however, the investigation could not rule out that patient samples were not, or would not be affected if the event were to recur undetected.There was no allegation of actual patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc.(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: 7312424
• MDR Text Key: 102079169
• Report Number: 3007111389-2018-00027
• 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: 03/05/2018

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: 08/29/2018
• Device Catalogue Number: 1912997
• Device Lot Number: 5550
• Other Device ID Number: 10758750000227
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/07/2018
• Initial Date FDA Received: 03/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2017
• 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