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

Catalog Number 1912997

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

Patient Problem Test Result (2695)

Event Date 07/22/2016

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that higher than expected vitros tsh results were obtained from two levels of non-vitros quality control fluid using vitros tsh reagent.A definitive assignable cause could not be determined.There was no evidence to suggest a vitros 5600 integrated system malfunction.Unexpected instrument performance is not a likely contributor to the events, however it cannot be entirely ruled out as a contributing factor as precision testing to assess instrument performance was not undertaken.Based on historical vitros tsh reagent lot 5198 quality control results, there is no indication a reagent related issue contributed to the event.

Event Description

The customer obtained higher than expected tsh results were obtained from non-vitros quality control fluids using vitros immunodiagnostic products tsh reagent on a vitros 5600 integrated system.Level 2 result of 6.110 miu/ml versus an expected result of 4.67 miu/ml; level 3 result of 31.23 miu/ml versus an expected result of 24.1 miu/ml.Biased results of the direction and magnitude observed could lead to inappropriate physician action.There was no report of patient harm as a result of this event.However, it cannot be concluded that patient sample results were not affected or would not be affected if the event were to recur undetected.This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTICS PRODUCT 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: 5886592
• MDR Text Key: 53446037
• Report Number: 3007111389-2016-00151
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• 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: 08/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: 1912997
• Device Lot Number: 5198
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2016
• 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