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 10/09/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation confirmed that lower than expected vitros tsh results were obtained from three different patient samples tested on a vitros eci immunodiagnostics system.A definitive assignable cause of the event could not be determined.However, a sample interferent that affects the vitros tsh assay could not be ruled out as contributing to the event.Details of additional medication or supplements being taken by the patients was requested but no information was given by the customer.Ongoing tracking and trending of complaint data has not identified any signals to suggest a systemic quality issue with tsh lot 5736.The customer performed within run precision testing using a vitros ttc control, the results were acceptable indicating the vitros eciq immunodiagnostic system was performing as expected and an instrument issue is not a likely contributing factor to this event.Additionally, pre-analytical sample processing could not be ruled out as a contributing factor as the customer is unaware of how the samples are processed prior to the facility receiving them.A definitive assignable cause could not be determined.

Event Description

A customer obtained lower than expected vitros tsh results from three different patient samples tested on a vitros eci immunodiagnostics system.The vitros tsh values obtained from the three patients were expected to fall within the euthyroid range of 0.465 ¿ 4.68miu/l based on other thyroid marker results that were deemed within the euthyroid range.Patient 1: 0.271 miu/l.Patient 2: 0.358 miu/l.Patient 3: 0.047 miu/l.Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected.The lower than expected vitros tsh results were reported outside of the laboratory and no additional testing was performed.There was no allegation of actual patient harm as a result of this event.This report is number two of three mdr¿s for this event.Three 3500a forms are being submitted for this event as a total of three devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho).Complaint numbers (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: 8075139
• MDR Text Key: 129192576
• Report Number: 3007111389-2018-00174
• 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: 11/15/2018

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: 06/07/2019
• Device Catalogue Number: 1912997
• Device Lot Number: 5736
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/19/2018
• Initial Date FDA Received: 11/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2018
• 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