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

Model Number 6192255

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2022

Event Type  malfunction  

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a higher than expected vitros nt pro-bnp ii result was obtained from a single patient sample when using vitros immunodiagnostics products nt pro-bnp ii reagent lot 0440 in combination with a vitros 5600 integrated system.Patient sample result of >30000 pg/ml versus the expected result of <300 pg/ml biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The discordant vitros result was not reported from the laboratory.Ortho has not been made aware of any 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 600489.

Manufacturer Narrative

The investigation determined that a higher than expected vitros nt pro-bnp ii result was obtained from a single patient sample when using vitros immunodiagnostics products nt pro-bnp ii reagent lot 0440 in combination with a vitros 5600 integrated system.A definitive assignable cause could not be determined with the information provided.Based on historical quality control results, a vitros lot 0440 performance issue is not a likely contributor to the event.However, it cannot be completely ruled out as the discordant result was generated on an expired reagent lot.An instrument related performance issue did not likely contribute to the event as the customer gave no indication of any instrument malfunction as all other tests predicted as expected.It was not possible to establish if the customer is following the sample collection device manufacturer¿s recommended centrifugation protocol; therefore, pre-analytical sample processing cannot be ruled out as a contributing factor.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.Additionally, the presence of an unknown sample specific interferent cannot be ruled out as contributing to the event.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros nt pro-bnp ii, lot 0440.

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS NT PROBNP REAGENT PACK
• Type of Device: IN-VITRO DIAGNSTICS
• 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: 16138781
• MDR Text Key: 307210390
• Report Number: 3007111389-2023-00008
• Device Sequence Number: 1
• Product Code: NBC
• UDI-Device Identifier: 10758750033300
• UDI-Public: 10758750033300
• Combination Product (y/n): N
• Reporter Country Code: PM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/10/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2022
• Device Model Number: 6192255
• Device Catalogue Number: 6802156
• Device Lot Number: 0440
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2022
• Initial Date FDA Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1