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 11/02/2023

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 a vitros xt 7600 integrated system.A definitive assignable cause for the higher and lower than expected vitros ipth results could not be determined.A historical review of qc results for the vitros ipth lot 1830 indicates acceptable reagent performance.Additionally, continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros ipth reagent lots 1830.Based on the acceptable quality control results obtained from within run diagnostic precision testing using vitros tsh assay, an instrument related performance issue did not contribute to the event.No information was provided by the customer on how long the customer leaves the qc vials to reach room temperature or how long the qc vials had been opened.The biorad package insert states, once thawed, opened, and stored tightly capped at 2 to 8 degrees c, vitros ipth will be stable for seven (7) days.Therefore, it is possible qc sample handling and storage could be a contributor to this event.

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 a vitros xt 7600 integrated system.Biorad lot 64971 level 2 result of 259.80 pg/ml versus the expected result of 198.00 pg/ml biorad lot 64971 level 3 results of 834.00, 833.00 and 7.50 pg/ml versus the expected result of 634.00 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 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 corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) 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: 18237963
• MDR Text Key: 329376723
• Report Number: 3007111389-2023-00205
• 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: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2024
• Device Catalogue Number: 6802892
• Device Lot Number: 1830
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1