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

Catalog Number	6192255
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that a lower than expected nt-probnp ii (nbnp2) result was obtained when a level 3 biorad qc fluid was processed using vitros nbnp2 lot 0260 on a vitros xt 7600 integrated system.A definitive assignable cause of the event was not established.Historical qc results leading up to the event indicate acceptable performance of vitros nbnp2 lot 0260.Additionally, ongoing tracking and trending of complaint data did not identify any signals to suggest there is a systemic quality issue with vitros nbnp2 lot 0260.An instrument issue cannot be ruled out as a contributor to the event, as no diagnostic precision testing was conducted around the time the lower than expected result was obtained to verify the performance of the vitros xt 7600 integrated system.It is possible improper handling of the biorad qcs contributed to the event, however, this could not be confirmed, as it was not possible to determine whether the customer handled the biorad level 3 qc according to the instructions prior to processing the fluid on the instrument.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a lower than expected nt-probnp ii (nbnp2) result was obtained when a level 3 biorad qc fluid was processed using vitros nbnp2 lot 0260 on a vitros xt 7600 integrated system.Biorad 67703 result of 42.45 pg/ml versus the baseline mean result of 2500 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 nbnp2 result was obtained when the customer was processing a non-patient fluid.There has been no allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint numbers (b)(4) and reportability assessment 607157.

• 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 ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 20089762
• Report Number: 3007111389-2024-00166
• Device Sequence Number: 7765014
• Product Code: NBC
• UDI-Device Identifier: 10758750033300
• UDI-Public: (01)10758750033300(17)240618(11)231220(10)0260
• 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): 08/28/2024

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: 06/18/2024
• Device Catalogue Number: 6192255
• Device Lot Number: 0260
• 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: 08/01/2024
• Initial Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2023
• 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