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

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 07/02/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that a higher than expected vitros tsh result was obtained from a single patient sample when tested on a vitros 3600 immunodiagnostic system using vitros tsh reagent lot 5860 when compared to results obtained from a non-vitros abbott system.A definitive assignable cause was not identified, however, the presence of an unknown sample interferent or possible sample mix up cannot be ruled out as contributing to the event.Based on historical quality control results, a vitros tsh lot 5860 performance issue is not a likely contributor to the event.Additionally, there is no indication of an instrument malfunction and unexpected instrument performance is not a likely contributor to the event as precision testing performed was within ortho acceptable guidelines.However, as this precision testing was not performed at the time of the event, an instrument issue cannot be completely ruled out as a potential cause of the event.In addition, pre-analytical sample processing could not be ruled out as a contributing factor, as it was not possible to establish if the customer was following the sample collection device manufacture¿s recommendation for sample centrifugation and cellular debris, due to poor sample preparation, was possibly present in the affected sample, although this could not be confirmed.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros tsh reagent lot 5860.The vitros results were reported from the laboratory and treatment was initiated based on the reported vitros results.However, corrected reports were later issued, and treatment was ceased.Ortho has not been made aware of any allegation of patient harm as a result of this event.

Event Description

An ortho clinical diagnostics (ortho) laboratory specialist (ls) contacted the ortho technical solutions center (tsc) on behalf of a customer to report higher than expected tsh patient sample results obtained using a vitros immunodiagnostic products tsh reagent on a vitros 3600 immunodiagnostic system when compared to tsh results obtained using a non-vitros abbott system at another laboratory.The date of the event was (b)(6) 2019.Tsh patient sample 1 result of 0.514 miu/l versus the expected results of 0.39 miu/l.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The vitros results were reported from the laboratory and treatment was initiated based on the reported vitros results.However, corrected reports were later issued, and treatment was ceased.Ortho has not been made aware of any allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK
• Type of Device: IN VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO CLINICAL DIAGNOSTICS; felindre meadows; pencoed; bridgend, wales CF35 5PZ; UK CF35 5PZ
• 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: 8916474
• MDR Text Key: 219775839
• Report Number: 3007111389-2019-00119
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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: 08/21/2019

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: 01/03/2020
• Device Catalogue Number: 1912997
• Device Lot Number: 5860
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/23/2019
• Initial Date FDA Received: 08/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2019
• 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