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

Catalog Number 6802892

Device Problem Low Test Results (2458)

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

Event Date 02/07/2024

Event Type  malfunction  

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected vitros intact pth (ipth) results were obtained from patient samples tested on a vitros xt 7600 integrated system when compared to results obtained on a vitros analyzer at their sister site.Sample 1, vitros ipth lot 1900 result of 46.3 versus sister site expected result of ipth 82.08 pg/ml sample 2, vitros ipth lot 1900 result of 50 versus sister site expected result of ipth 72.91 pg/ml sample 3, vitros ipth lot 1900 result of 311 sister site expected result of ipth 464.1 pg/ml sample 8, vitros ipth lot 1900 result 816.5 sister site expected result of ipth 1167.3 pg/ml sample 14, vitros ipth lot 1900 result 797.9 sister site expected result of ipth 1309.5 pg/ml biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The lower than expected vitros ipth patient results were not reported outside of the laboratory as they were part of a correlation study.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 lower than expected vitros intact pth (ipth) results were obtained from patient samples tested on a vitros xt 7600 integrated system when compared to results obtained on a vitros analyzer at their sister site.The assignable cause of the event was not determined.A review of calibration parameters indicated that while calibrations from both vitros xt 7600 analyzers in the laboratory passed, the calibration on j76000953 was suboptimal and could have contributed to the event.In additional, the biorad level 2 result post calibration for j76000953 was not within 2sd range.Pre-analytical handling of calibrator fluids was a potential contributing factor as the customer was not calibrating both analyzers at the same time.Intact pth is labile and susceptible to fragmentation.Correct handling of patient samples is necessary to ensure that the pth molecule remains intact.The degree of fragmentation will depend on both time and temperature of storage.The pre-analytical sample handling could not be confirmed or ruled out as a potential contributing factor of the event.There was no indication of a vitros xt 7600 instrument issue, and an instrument malfunction is not a likely contributor to the event.

• 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 ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 18848513
• MDR Text Key: 337868642
• Report Number: 3007111389-2024-00051
• 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: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• 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: 1900
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1