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

Catalog Number	6802892
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that lower than expected intact pth (ipth) results were obtained when non-vitros (mas) qc fluids were tested using vitros ipth lot 1950 on a vitros xt 7600 integrated system.A definitive cause of the event was not established.A vitros ipth lot 1950 reagent issue cannot be ruled out as a contributor to the event, as imprecision was observed from historical testing of mas qc fluids.However, vitros ipth lot 1950 results from mas qc testing since the latest event were acceptable and ongoing tracking and trending did not identify any signals to suggest there is a systemic quality issue with vitros ipth lot 1950.The lower than expected results were isolated to the testing of mas qc fluids and it is possible improper handling of the mas qcs contributed to the event.Ipth is susceptible to fragmentation and it could not be determined whether the customer was handling the mas qcs according to instructions for each testing event when the lower than expected results were obtained.An instrument issue cannot be ruled out as a contributor to the event, as no within run diagnostic precision was conducted to rule out the performance of the vitros xt 7600 integrated system around the time the lower than expected results were obtained.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected intact pth (ipth) results were obtained when non-vitros (mas) qc fluids were tested using vitros ipth lot 1950 on a vitros xt 7600 integrated system.Mas oim27031a (level 1) results of 18.10, 18.40, 12.55, 17.38, 18.67, 19.45, 17.39, 18.83, 18.67 and 18.01 pg/ml versus the customer's estimated baseline mean result of 28 pg/ml mas oim27033a (level 3) result of 741.09 pg/ml versus the customer's estimated baseline mean result of 1229 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 lower than expected vitros ipth results were obtained when the customer was processing non-patient fluids.There has been no allegation of patient harm as a result of this event.This report is number two of three mdrs for this event.Three 3500a forms are being submitted for this event as three devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment 607099.

• 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 ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 20014090
• Report Number: 3007111389-2024-00158
• Device Sequence Number: 7164246
• Product Code: CEW
• UDI-Device Identifier: 10758750006267
• UDI-Public: (01)10758750006267(17)241125(11)240219(10)1950
• 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): 08/15/2024

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: 11/25/2024
• Device Catalogue Number: 6802892
• Device Lot Number: 1950
• 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: 07/25/2024
• Initial Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2024
• 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