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

Catalog Number 6900052

Device Problem Low Test Results (2458)

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

Event Date 02/07/2024

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that discordant, higher than expected vitros ipth (lot 1860) results were obtained when multiple patient samples were tested on a vitros xt7600 integrated system.The results were discordant when compared to vitros ipth2 results for the same patient samples.In addition, a discordant, lower than expected vitros ipth2 (lot 0020) results was obtained from a single patient sample when tested on the same vitros xt7600 integrated system.The results were discordant when compared to vitros ipth results for the same patient sample.The most likely cause of the discordant, higher than expected vitros ipth lot 1860 results is a suboptimal calibration.The calibrator 2 and calibrator 3 responses were low for the affected calibration (cal id 1690), which resulted in biased high results for patients 1-24 as well as biased high results from biorad/vitros qc testing.The calibrator responses were acceptable upon recalibration vitros ipth lot 1860 and the subsequent results from patient and qc testing have also been deemed acceptable.A definitive assignable cause of the discordant, lower than expected vitros ipth2 lot 0020 result for patient 41 was not established.Qcs were not processed to verify vitros ipth2 lot 0020 reagent assay performance on the date the discordant, lower than expected vitros ipth2 lot 0020 result was obtained for patient 41.Therefore, a vitros ipth2 lot 0020 performance issue cannot completely be ruled out as a contributor to the event.The time between vitros ipth and vitros ipth2 is an unlikely cause of the discordance observed between the results for patient 41, as the tests were process on the vitros system at the same time.There was no evidence of an instrument malfunction, however, as no diagnostic precision testing was conducted on the date of the event the discordant, lower than expected vitros ipth2 lot 0020 result was obtained for patient 41, an instrument issue cannot be ruled out as a contributor to the event.Ongoing tracking and trending of complaint data did not identify any signals to suggest there is a systemic quality issue with vitros ipth lot 1860 or vitros ipth2 lot 0020.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report discordant, higher than expected vitros ipth (lot 1860) results were obtained when multiple patient samples were tested on a vitros xt7600 integrated system.The results were discordant when compared to vitros ipth2 results for the same patient samples.In addition, a discordant, lower than expected vitros ipth2 (lot 0020) results was obtained from a single patient sample when tested on the same vitros xt7600 integrated system.The results were discordant when compared to vitros ipth results for the same patient sample.Patient 1, vitros ipth lot 1860 result of 75.02 pg/ml versus the vitros ipth2 results of 42.08 and 40.32 pg/ml patient 2, vitros ipth lot 1860 result of 72.83 pg/ml versus the vitros ipth2 results of 50.17 and 49.44 pg/ml patient 3, vitros ipth lot 1860 result of 123.50 pg/ml versus the vitros ipth2 results of 68.26 and 68.39 pg/ml patient 4, vitros ipth lot 1860 result of 84.96 pg/ml versus the vitros ipth2 results of 52.50 and 51.93 pg/ml patient 5, vitros ipth lot 1860 result of 128.53 pg/ml versus the vitros ipth2 results of 78.95 and 77.78 pg/ml patient 6, vitros ipth lot 1860 result of 158.79 pg/ml versus the vitros ipth2 results of 90.38 and 91.72 pg/ml patient 7, vitros ipth lot 1860 result of 599.85 pg/ml versus the vitros ipth2 results of 164.63 and 162.70 pg/ml patient 8, vitros ipth lot 1860 result of 58.44 pg/ml versus the vitros ipth2 results of 24.13 and 23.00 pg/ml patient 9, vitros ipth lot 1860 result of 28.24 pg/ml versus the vitros ipth2 results of 17.70 and 18.74 pg/ml patient 10, vitros ipth lot 1860 result of 11.20 pg/ml versus the vitros ipth2 results of 6.50 and 6.15 pg/ml patient 11, vitros ipth lot 1860 result of 170.77 pg/ml versus the vitros ipth2 results of 91.03 and 88.97 pg/ml patient 12, vitros ipth lot 1860 result of 39.61 pg/ml versus the vitros ipth2 results of 26.30 and 26.25 pg/ml patient 13, vitros ipth lot 1860 result of 93.11 pg/ml versus the vitros ipth2 results of 48.85 and 46.94 pg/ml patient 14, vitros ipth lot 1860 result of 63.76 pg/ml versus the vitros ipth2 results of 32.31 and 31.40 pg/ml patient 15, vitros ipth lot 1860 result of 420.82 pg/ml versus the vitros ipth2 results of 130.58 and 130.96 pg/ml patient 16, vitros ipth lot 1860 result of 77.56 pg/ml versus the vitros ipth2 results of 39.40 and 39.16 pg/ml patient 17, vitros ipth lot 1860 result of 57.46 pg/ml versus the vitros ipth2 results of 29.30 and 29.27 pg/ml patient 18, vitros ipth lot 1860 result of 96.08 pg/ml versus the vitros ipth2 results of 46.28 and 46.13 pg/ml patient 19, vitros ipth lot 1860 result of 101.65 pg/ml versus the vitros ipth2 results of 60.77 and 59.02 pg/ml patient 20, vitros ipth lot 1860 result of 48.91 pg/ml versus the vitros ipth2 results of 33.91 and 33.29 pg/ml patient 21, vitros ipth lot 1860 result of 51.86 pg/ml versus the vitros ipth2 results of 31.31 pg/ml patient 22, vitros ipth lot 1860 result of 85.49 pg/ml versus the vitros ipth2 results of 51.04 pg/ml patient 23, vitros ipth lot 1860 result of 58.38 pg/ml versus the vitros ipth2 results of 36.90 pg/ml patient 24, vitros ipth lot 1860 result of 159.58 pg/ml versus the vitros ipth2 results of 92.95 pg/ml patient 41, vitros ipth2 lot 0020 result of 144.05 pg/ml versus the vitros ipth result of 207.41 pg/ml biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The discordant, vitros ipth and vitros ipth2 results were not reported from the laboratory as the results were obtained from a correlation study between the two methods.There has been no allegation of patient harm as a result of this event.This report is number one of two mdrs for this event.Two 3500a forms are being submitted for this event as two 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 II 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 ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 18841780
• MDR Text Key: 336960874
• Report Number: 3007111389-2024-00049
• Device Sequence Number: 1
• Product Code: CEW
• UDI-Device Identifier: 10758750032709
• UDI-Public: 10758750032709
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6900052
• Device Lot Number: 0020
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1