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

Model Number 6802892

Device Problem High Test Results (2457)

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

Event Date 06/21/2023

Event Type  malfunction  

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher than expected vitros intact pth (ipth) results were obtained from several patient samples when tested on a vitros 5600 integrated system.Vitros ipth lot 1776, patient 1 result of 84.51 pg/ml versus the expected non-vitros beckman result of 40 pg/ml and 59.6 pg/ml.Vitros ipth lot 1776, patient 2 result of 227.9 pg/ml versus the expected non-vitros beckman result of 148.2 pg/ml vitros ipth lot 1776, patient 3 result of 174.5 pg/ml versus the expected non-vitros beckman result of 117.5 pg/ml vitros ipth lot 1776, patient 5 result of 158.3 pg/ml versus the expected non-vitros beckman result of 103.4 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 results were not reported from the laboratory.Ortho has not been made aware of any 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 higher than expected vitros intact pth (ipth) results were obtained from several patient samples when tested on a vitros 5600 integrated system.A definitive assignable cause could not be determined with the information provided.The customer did not perform any precision testing on the instrument, so no assessment of the instrument performance at the time of the events was made.Therefore, an instrument issue could not be ruled out as contributing to the event.The customer uses a non-vitros beckman system at an alternative site to retest the vitros ipth samples.The time difference between the two sites is approximately 9 hours and the samples are frozen before shipping.The vitros ipth 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.Therefore, it is possible that improper sample handling between testing events contributed to the higher-than-expected patient sample results, however, this cannot be confirmed.In addition, the customer is not following the manufacturer¿s recommended sample handling protocol; therefore, incorrect 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 samples.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros ipth reagent lot 1776.

• 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: 17343180
• MDR Text Key: 319702656
• Report Number: 3007111389-2023-00119
• 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: 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2023
• Device Model Number: 6802892
• Device Catalogue Number: 6802892
• Device Lot Number: 1776
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1