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 Consequences Or Impact To Patient (2199)

Event Date 11/02/2015

Event Type  malfunction  

Manufacturer Narrative

A definitive assignable cause of this event was not determined.An instrument related issue cannot be entirely ruled out as a contributing factor.In addition, an unknown sample interferent that affects the vitros assay but not the non vitros assays cannot be ruled out as contributing to the event.The issue is isolated to one sample from two specific patients.There is no evidence that would suggest a vitros tsh issue with either one of the vitros tsh reagent lots in use contributed to the event.

Event Description

The customer observed two lower than expected vitros tsh results from two different patient samples using vitros tsh reagent on a vitros 5600 integrated system when compared to tsh results obtained from two non vitros methods.Patient 1 tsh result < 0.015 miu/l vs.Non vitros tsh result 2.03 miu/l.Patient 2 tsh result < 0.015 miu/l vs.Non vitros tsh result 0.955 miu/l.Biased patient results of the direction and magnitude observed may lead to inappropriate physician action.The lower than expected vitros tsh results of 0.015 miu/l were reported outside of the laboratory, however, no treatment was given, changed, or withheld based on the reported tsh results, and there was no allegation of patient harm as a result of this event.This report is number two of two mdr's for this event.Two 3500a forms are being submitted for this event as two devices were involved.(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: 5345363
• MDR Text Key: 35492378
• Report Number: 3007111389-2016-00001
• 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: 01/05/2016

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: 06/10/2016
• Device Catalogue Number: 1912997
• Device Lot Number: 4880
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/07/2015
• Initial Date FDA Received: 01/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2015
• 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