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 11/22/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher and lower than expected vitros intact pth (ipth) quality control (qc) results were obtained when using non-vitros biorad quality control (qc) fluid on two different vitros 5600 integrated systems.The customer also processed calibrator fluids as a patient sample and obtained lower than expected results.The assignable cause for the higher and lower than expected, intact pth (ipth) results could not be determined.Calibration responses were within the allowable ranges.However, low adjusted light units (alu) responses likely generated a suboptimal calibration which subsequently impacted assay results obtained from each calibration.Historical qc fluid performance indicates a vitros ipth lot 1860 performance issue could be a likely contributor to the event as the customers qcs revealed unacceptable accuracy.However, following recalibration using a new calibration kit, all qc results processed were within range.Therefore, the performance of the vitros ipth reagent lot 1860 can be ruled out as contributing to the event.No precision testing was performed on the vitros 5600 integrated systems at the time of the event and historical vitros qc fluid results were not precise, therefore, an instrument related issue cannot be entirely ruled out as a contributor of the events.In addition, sample handling and storage cannot be ruled out as a contributing factor as the customer stores both the biorad qc and the vitros qc fluids in a refrigerator and allows the qc to thaw for fifteen (15) minutes before reconstituting using fixed 1 ml pipette and di water.Allowing qcs to thaw for fifteen minutes prior to use is not an adequate amount of time to allow the qcs to reach 15¿30 degrees c (59¿86 degrees f).Therefore, sample handling cannot be ruled out as a contributing factor to the event.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros ipth reagent lot 1860.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher and lower than expected vitros intact pth (ipth) quality control (qc) results were obtained when using non-vitros biorad quality control (qc) fluid on two different vitros 5600 integrated systems.The customer also processed calibrator fluids as a patient sample and obtained lower than expected results.Biorad level 1 qc results of 129.7 and 116.5 pg/ml vs the expected result of 53.50 pg/ml.Biorad level 3 qc results of 1817.0 and 1647.6 pg/ml vs the expected result of 761.00 pg/ml.Vitros level 1 qc results of 76.40, 75.20, 79.03, 70.12, 70.06, 74.53, 74.93, 79.60 and 77.30 pg/ml vs the expected result of 32.40 pg/ml.Vitros level 2 qc results of 190.20, 183.30, 176.57, 173.22, 180.94, 185,35, 180.04, 188.00 and 184.90 pg/ml vs the expected result of 76.70 pg/ml.Vitros level 3 qc results of 1227.6, 1229.9, 1115.84, 1061.88, 1093.11, 1136.16, 1087.55, 1138.8 and 1184.1 pg/ml vs the expected result of 472.70 pg/ml.Calibrator 2 result of 38.00 pg/ml vs expected result of 109.1 pg/ml.Calibrator 3 result of 537.00 pg/ml vs expected result of 1530.00 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 higher and lower than expected vitros ipth results were obtained when the customer was processing non-patient fluids.No patient samples were processed during the time of the event.Ortho has not been made aware of any allegation of harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint numbers (b)(4), 2 and reportability assessment (b)(6).

• 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: 18486372
• MDR Text Key: 332917204
• Report Number: 3007111389-2024-00006
• 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: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• 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: 1860
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1