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

Catalog Number 1912997

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/23/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that a non-reproducible, imprecise vitros tsh results were obtained from samples from three different patients when tested on a vitros 5600 integrated system using a vitros tsh reagent lot 6530.A definitive assignable cause for the non-reproducible, imprecise vitros tsh results could not be established with the information provided.The customer did not provide any qc fluid information leading up to the event so it was not possible to make an appropriate assessment of the vitros tsh reagent performance at the time of the event.Additionally, precision testing of the vitros 5600 integrated system was not performed, therefore it cannot be confirmed that the instrument was operating as intended and unexpected instrument performance cannot be completely ruled out as contributing to the event.In addition, pre-analytical sample processing could not be ruled out as a contributing factor, as it was established that the customer was not following the sample collection device manufacture¿s recommendation for sample centrifugation.Therefore, improper pre-analytical sample handling could have contributed to this event.It is possible that cellular debris, due to poor sample preparation contributed to this event, although this could not be confirmed.Furthermore, poor laboratory practices at the customer site cannot be completely ruled out as contributing to the event.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros tsh reagent lot 6530.Email address for contact office is (b)(4).

Event Description

The investigation has determined that a non-reproducible, imprecise vitros tsh results were obtained from samples from three different patients when tested on a vitros 5600 integrated system using a vitros tsh reagent lot 6530.Patient 1 result of 1.88 miu/l versus the expected result of 4.25 miu/l.Patient 1 result of 4.25 miu/l versus the expected result of 1.88 miu/l.Patient 2 result of 0.49 miu/l versus the expected result of 1.05 miu/l.Patient 2 result of 1.05 miu/l versus the expected result of 0.49 miu/l.Patient 3 result of 0.56 miu/l versus the expected result of 1.16 miu/l.Patient 3 result of 1.16 miu/l versus the expected result of 0.56 miu/l.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The customer confirmed that the non-reproducible, imprecise vitros tsh results were not reported from the laboratory to a physician and 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 (ortho) complaint number (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK
• Type of Device: IN-VITRO DIAGNOSTICS
• 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: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 12668616
• MDR Text Key: 277719367
• Report Number: 3007111389-2021-00136
• 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: Physician
• Type of Report: Initial
• Report Date: 10/20/2021

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: 03/10/2022
• Device Catalogue Number: 1912997
• Device Lot Number: 6530
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/23/2021
• Initial Date FDA Received: 10/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2021
• 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