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

Catalog Number	6802893
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that higher than expected vitros intact pth (ipth) results were obtained while processing a single patient sample and a single level of non-vitros biorad liquichek specialty immunoassay control fluid with vitros ipth lot 2000 on a vitros xt 7600 integrated system.The assignable cause of the event was sample testing using a suboptimal ipth calibration.The cause of the suboptimal calibration was not determined.The higher than expected biorad qc and patient results were both obtained from the same ipth lot 2000 calibration curve.A review of the calibration parameters concluded the calibration was suboptimal.In addition, the ipth qc results post calibration were unacceptable indicating the calibration was unacceptable.It is concluded that sample testing using the suboptimal ipth lot 2000 calibration caused the higher than expected results.The customer discontinued using vitros ipth lot 2000 and moved to an alternate ipth reagent lot 2020.The customer was satisfied with performance and no further investigation was performed.An instrument related performance issue did not likely contribute to the event as acceptable results were obtained using alternate vitros ipth reagent lot 2020 without performing any actions to the vitros xt 7600 integrated system.In addition, there was no indication of an instrument malfunction, further verifying that an unexpected instrument performance issue is not a likely contributor to the event.Improper sample storage and processing did not likely contribute to the event as the affected patient sample was stored per the vitros ipth instructions for use.
Event or Problem 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 while processing a single patient sample and a single level of non-vitros biorad liquichek specialty immunoassay control fluid with vitros ipth lot 2000 on a vitros xt 7600 integrated system.Biorad lot 65000, level 2 result of 282.6 pg/ml versus the expected result of 211.4 pg/ml patient sample a ipth result of 55.2 pg/ml versus the expected result of 41.0 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 than expected vitros ipth results were obtained from a correlation sample as well as a biorad qc fluid and results were not reported outside of the laboratory.There was no 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)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH CALIBRATORS
• Common Device Name: 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: 20422843
• Report Number: 3007111389-2024-00195
• Device Sequence Number: 7608163
• Product Code: CEW
• UDI-Device Identifier: 10758750006250
• UDI-Public: (01)10758750006250(17)250303(11)240525(10)2000
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/03/2025
• Device Catalogue Number: 6802893
• Device Lot Number: 2000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown