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

Model Number	6802220
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has determined that lower than expected vitros nt probnp ii (ntbnp ii) results were obtained from two different patient samples when tested using vitros ntbnp ii lot 0039 on a vitros 5600 integrated system and a vitros 3600 immunodiagnostic system.A definitive cause of the event was not determined with the information provided.Based on quality control results a reagent performance issue is not likely a contributor to the event.There is no evidence of an instrument malfunction, and the customer gave no indication of any instrument malfunction during the investigation.Additionally, the vitros ntbnp ii sample results were concordant between the vitros 5600 and a vitros 3600 system.Therefore, an issue with the vitros 5600 integrated system or vitros 3600 immunodiagnostic system is an unlikely contributor to the event.However, as no precision testing was performed on the instruments around the time of the event, an instrument related issue cannot be entirely ruled out as a contributing factor of the event.Additionally, patient sample mix up could not be ruled out as a contributor of the event as it was not possible to determine if the discordant results were obtained from the same sample cups when processed on (b)(6) 2022.No information regarding the age or sex of any of the patient samples as well as any medications or supplements the patients may have been taking was available.In addition, the samples were not retested using any blocking tubes.Therefore, a sample interferent cannot be ruled out as a possible contributing factor of the event.The ortho laboratory specialist stated that some of the samples were outside of ortho stability claims as stated in the instructions for use but could not confirm the collection dates.Therefore, a sample stability related issue cannot be ruled out as a possible contributor of the event.Continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros ntbnp ii reagent lot 0039.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected vitros nt probnp ii (ntbnp ii) results were obtained from two different patient samples when tested using vitros ntbnp ii lot 0039 on a vitros 5600 integrated system and a vitros 3600 immunodiagnostic system.Vitros 5600: patient 11 sample vitros ntbnp ii result of 232 pg/ml vs an expected result of 2166 pg/ml.Patient 20 sample vitros ntbnp ii result of 3810 pg/ml vs an expected result of 6220 pg/ml vitros 3600: patient 11 sample vitros ntbnp ii result of 230 pg/ml vs an expected result of 2166 pg/ml.Patient 20 sample vitros ntbnp ii result of 3900 pg/ml vs an expected result of 6220 pg/ml.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The results were not reported outside of the laboratory as they were obtained during validation testing.There is no allegation of patient harm as a result of this event.This report is number one of two mdr¿s for this event.Two 3500a forms are being submitted for this event as two devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS NT PROBNP II 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: 16629091
• Report Number: 3007111389-2023-00052
• Device Sequence Number: 20161297
• Product Code: NBC
• UDI-Device Identifier: 10758750002320
• UDI-Public: 10758750002320
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (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): 03/27/2023

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: 03/07/2023
• Device Model Number: 6802220
• Device Catalogue Number: 6192255
• Device Lot Number: 0039
• 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: 02/28/2023
• Initial Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2022
• 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