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

Catalog Number 6802892

Device Problem High Test Results (2457)

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

Event Date 01/16/2024

Event Type  malfunction  

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a higher than expected vitros intact pth (ipth) result was obtained from a single patient sample when tested on a vitros xt 7600 integrated system.The result was discordant when compared to a non-vitros siemans atellica ipth result for a second sample from the same patient.Patient 1, ipth lot 1851, result of 111.00 pg/ml versus the expected result of 68.00 pg/ml biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The higher than expected vitros ipth result of 111.00 pg/ml was reported from the laboratory.However, no treatment was initiated, altered, or stopped based on the reported result.There was no allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment (b)(4).

Manufacturer Narrative

The investigation determined that a higher than expected vitros intact pth (ipth) result was obtained from a single patient sample when tested on a vitros xt 7600 integrated system.The result was discordant when compared to a non-vitros siemans atellica ipth result for a second sample from the same patient.A definitive assignable cause of the higher than expected vitros ipth result could not be determined.Based on historical quality control results, a vitros ipth lot 1851 performance issue is not a likely contributor to the event.Within run vitros tsh precision testing carried out indicated acceptable instrument performance approximately a month after the event, however, as no precision testing was carried out at the time of the event a transient instrument issue cannot be entirely ruled out as a contributing factor.The customer did not provide the pre-analytical sample handling protocol; therefore, it cannot be determined if the customer was following the sample collection device manufacture's recommendation for sample centrifugation, consequently, improper pre-analytical sample handling could have contributed to this event.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.It is possible an unknown interferent that affects the vitros ipth method and not the non-vitros siemans atellica method contributed to the event, however, this cannot be confirmed as the customer did not have any patient sample left for re-testing and the customer declined to call the patient back for additional testing.Additionally, as the patient was taking a number of different medications and suffers from a number of medical conditions, it is possible that the patient's clinical conditions and medications contributed to the higher than expected vitros ipth result.The vitros ipth instructions for use, other limitations sections states "certain drugs and clinical conditions are known to alter pth concentrations in vivo.For additional information, refer to one of the published summaries.".

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK
• Type of Device: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; felindre meadows; pencoed; bridgend NY CF35 5PZ; UK CF35 5PZ
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS; felindre meadows; pencoed; bridgend CF35 5PZ; UK CF35 5PZ
• Manufacturer Contact: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 18920539
• MDR Text Key: 337855552
• Report Number: 3007111389-2024-00056
• Device Sequence Number: 1
• Product Code: CEW
• UDI-Device Identifier: 10758750006267
• UDI-Public: 10758750006267
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6802892
• Device Lot Number: 1851
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1