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

Model Number	6802893
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that higher than expected vitros intact pth (ipth) results were obtained from vitros ipth reagent lot 1650 tested with two levels of non-vitros seronorm control fluids, lot 2010905, tested on a vitros xt7600 integrated system.The assignable cause for the higher than expected vitros ipth reagent lot 1650 results was a suboptimal calibration.The cause of the suboptimal calibration was not determined.The customer performed no actions other then to recalibrate vitros ipth lot 1650 and the qc results post recalibration were as expected.There was no indication of an issue with the vitros xt7600 system and therefore, the instrument was not a likely contributor to the event.
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 from vitros ipth reagent lot 1650 tested with two levels of non-vitros seronorm control fluids, lot 2010905, tested on a vitros xt7600 integrated system.Seronorm level 1 results of 27.3 and 26.6 pg/ml vs.The expected result of 19.0 pg/ml.Seronorm level 2 results of 141.9 and 139.6 pg/ml vs.The expected result of 90.2 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 non-patient quality control fluids and were not reported from the laboratory.The customer made no indication that patient samples were affected and 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 601564.

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK
• 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 ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 16799905
• Report Number: 3007111389-2023-00063
• Device Sequence Number: 6386361
• Product Code: CEW
• UDI-Device Identifier: 10758750006250
• UDI-Public: 10758750006250
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2023

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: 05/29/2023
• Device Model Number: 6802893
• Device Catalogue Number: 6802893
• Device Lot Number: 1650
• 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: 03/27/2023
• Initial Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2022
• 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