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

Catalog Number 6802892

Device Problems High Test Results (2457); Low Test Results (2458)

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

Event Date 09/10/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that lower and higher than expected vitros intact pth (ipth) quality control fluid results were obtained when processing non-vitros mas omni-immune qc fluids using two different vitros intact pth reagent lots in conjunction with two different vitros xt 7600 integrated systems.An assignable cause for the lower and higher than expected vitros ipth results could not be determined.A review of qc fluid results indicates there has been imprecision and accuracy issues at the customer site since the reagents were put into use.Therefore, a performance issue with vitros ipth reagent lots 1734 and 1760 cannot be ruled out as a contributor to the event.However, continual tracking and trending of complaints has not identified any signals that would indicate a systematic issue with vitros ipth reagent lots 1734 or 1760.Based on the acceptable quality control results obtained from within run precision testing using vitros tsh assay, an instrument issue is an unlikely contributor to the event.However, as no diagnostic within-run precision testing was performed on any of the two vitros xt 7600 integrated systems at the time of the events, an instrument related issue cannot be completely ruled out as contributing to the events.The customer did not state how long the qc fluids had been opened and stored between testing events.Additionally, there is inconsistency between the mas omni-immune instructions for use (ifu) and the vitros ipth ifu with regards to processing the qc fluids.Therefore, it is possible handling, storage and processing of the qc fluids could be a contributor to the events.

Event Description

The investigation determined that lower and higher than expected vitros intact pth (ipth) quality control fluid results were obtained when processing non-vitros mas omni-immune qc fluids using two different vitros intact pth reagent lots in conjunction with two different vitros xt 7600 integrated systems.Mas lot oim 2302 level 1 results of 10.04, 9.98, 12.31, 11.84, 9.99, 10.13, 10.28, 10.70, 14.24, 13.83, 13.39, 12.40, 10.75, 3.4, 7.47, 8.80, 11.46, 12.17, 12.69, 9.41, 10.93, 10.74, 10.33, 13.41, 12.49, 13.00, 10.68, 12.61, 11.81, 12.07 and 11.89 pg/ml versus the expected result of 21.00 pg/ml mas lot oim 2703 level 1 results of 38.4, pg/ml versus the expected result of 28.00 pg/ml mas lot oim 2411 level 2 results of 49.12, 50.93, 50.03, 31.51, 47.07, 40.56, 34.84, 33.65, 32.74, 25.92, 32.02 and 31.70 pg/ml versus the expected result of 76.90 pg/ml biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The lower and higher than expected vitros ipth results obtained were from non-patient fluids.Ortho is not aware of any reported allegation of patient harm as a result of this event.This report is number three of three mdr¿s for this event.Three 3500a forms are being submitted for this event as three devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint numbers (b)(4) and reportability assessment (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK
• Type of Device: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS; felindre meadows; pencoed; bridgend CF35 5PZ; UK CF35 5PZ
• Manufacturer Contact: laurie o'riordan ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 18083603
• MDR Text Key: 327515710
• Report Number: 3007111389-2023-00191
• Device Sequence Number: 1
• Product Code: CEW
• UDI-Device Identifier: 10758750006267
• UDI-Public: 10758750006267
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/27/2023
• Device Catalogue Number: 6802892
• Device Lot Number: 1760
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1