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

Catalog Number 1912997

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Readings (2460)

Patient Problem Test Result (2695)

Event Date 06/17/2016

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that lower than expected tsh results were obtained from two vitros quality control fluids and two patient samples using vitros immunodiagnostics products tsh reagent in combination with a vitros 5600 integrated system.The most likely assignable cause of the lower than expected qc results is the use of an expired calibration by the user.The results detailed above were obtained on (b)(6) 2016 using a calibration from (b)(6) 2015.Per the vitros tsh instructions for use the assay should be calibrated at least every 28 days.Additionally, insufficient quality control data was available for analysis to completely rule out a reagent performance issue and precision testing was not performed so unexpected instrument performance can also not be entirely ruled out as contributing to the events.The customer recalibrated their instrument and obtained acceptable qc results and was consequently satisfied with the performance of the tsh reagent.

Event Description

A customer obtained four lower than expected vitros tsh results from two vitros quality control fluids and two patient samples when processed on a vitros 5600 integrated system.(b)(6).Biased results of the direction and magnitude observed may lead to inappropriate physician action.The lower than expected vitros tsh patient results were not reported from the laboratory and the customer ceased routine tsh testing as a result of the obtained results.Ortho clinical diagnostics (ortho) has not been made aware of erroneous vitros tsh patient results obtained or reported from the laboratory over the time frame of the events.There was no allegation of patient harm as a result of these events.(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: 5781806
• MDR Text Key: 50190894
• Report Number: 3007111389-2016-00116
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 07/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/05/2016
• Device Catalogue Number: 1912997
• Device Lot Number: 4970
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2015
• 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