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

Catalog Number	1896836
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher than expected ck-mb results were obtained from a single patient sample processed using vitros immunodiagnostic products ck-mb reagent lot 3710 on a vitros xt 7600 integrated system.Patient sample results of 40.405 and 41.342 ng/ml vs.The expected result of 0.551 ng/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 vitros ck-mb patient sample result of 40.405 ng/ml was reported from the laboratory.However, a physician questioned the result and a corrected report was later issued.No treatment was initiated, altered or stopped based on the higher-than-expected result and there have been no reported allegations 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).
Additional Manufacturer Narrative
The investigation has determined that higher than expected ck-mb results were obtained from a single patient sample processed using vitros immunodiagnostic products ck-mb reagent lot 3710 on a vitros xt 7600 integrated system.A definitive assignable cause could not be determined.Based on historical quality control results, a vitros ck-mb reagent lot 3710 performance issue is not a likely contributor of the event.Additionally, continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros ck-mb reagent lot 3710.Precision testing was not performed on the vitros xt 7600 integrated system; therefore, an instrument related issue cannot be entirely ruled out as a contributor of the event.However, an instrument related issue was not likely a contributor to the event as historical qc results were precise and expected results were obtained for the patient from a redraw sample without any actions being performed on the vitros xt 7600 system.Pre-analytical sample processing could not be ruled out as a contributing factor as it is unknown if the customer was following the sample collection device manufacturer's recommended centrifugation protocol.Improper pre-analytical sample handling could have contributed to the event.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.Additionally, after analysis of e-connectivity data, a sample mix-up could not be confirmed or entirely ruled out as a cause of the event.The patient was taking medications at the time of the event; however, the specific medications were not provided.Therefore, a sample interferent cannot be ruled out as a contributing factor of the event.

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB 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: 20476518
• Report Number: 3007111389-2024-00206
• Device Sequence Number: 20899685
• Product Code: JHX
• UDI-Device Identifier: 10758750000203
• UDI-Public: (01)10758750000203(17)250221(11)240423(10)3710
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 10/17/2024

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: 02/21/2025
• Device Catalogue Number: 1896836
• Device Lot Number: 3710
• 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: 09/21/2024
• Initial Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2024
• 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