MAUDE Adverse Event Report: ORTHO CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTICS PRODUCTS NT-PROBNP II REAGENT PACK; IN-VITRO DIAGNOSTICS

Catalog Number 6844452

Device Problem High Test Results (2457)

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

Event Date 03/31/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a discordant, higher than expected vitros nt ¿ probnp ii (ntbnp ii) result was obtained from a single patient sample when tested using vitros ntbnp ii lot 0360 on a vitros xt7600 integrated system.The result was discordant when compared to a nt ¿ probnp result for the same patient.A definitive cause of the event was not established with the limited information provided.A vitros ntbnp ii lot 0360 reagent issue is an unlikely contributor to the event, as historical qc results leading up to the event suggested acceptable vitros ntbnp ii lot 0360 performance.Additionally, ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros ntbnp ii lot 0360.There was no evidence of an instrument malfunction.However, as no diagnostic precision testing was conducted around the time of the event, an instrument issue cannot be completely ruled out as a contributor to the event.No information was provided in relation to the pre-analytical handling of the sample from the patient.Improper pre-analytical sample handling could have contributed to this 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, an interferent that affects the vitros ntbnp ii method and not the method the ntbnp result of 31 pg/ml was obtained on cannot be ruled out as a contributor to the event.No information was provided in relation to further testing conducted on the patient sample to rule out the presence of a sample interferent.Email address for contact office above is (b)(4).

Event Description

The investigation determined that a discordant, higher than expected nt ¿ probnp ii (ntbnp ii) result was obtained from a single patient sample when tested using vitros ntbnp ii lot 0360 on a vitros xt7600 integrated system.The result was discordant when compared to a nt ¿ probnp result for the same patient.Patient 1, vitros ntbnp ii result of 4279.81 pg/ml (above the decision threshold) versus a ntbnp result of 31 pg/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 ntbnp ii result was reported from the laboratory.However, no treatment was altered, initiated or stopped based on the reported result.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 numbers (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTICS PRODUCTS NT-PROBNP II REAGENT PACK
• Type of Device: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO CLINICAL DIAGNOSTICS; felindre meadows; pencoed; bridgend, wales CF35 5PZ; UK CF35 5PZ
• Manufacturer (Section G): ORTHO CLINICAL DIAGNOSTICS; felindre meadows; pencoed; bridgend, wales CF35 5PZ; UK CF35 5PZ
• Manufacturer Contact: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 14511196
• MDR Text Key: 300586242
• Report Number: 3007111389-2022-00049
• Device Sequence Number: 1
• Product Code: NBC
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/26/2022

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: 06/21/2022
• Device Catalogue Number: 6844452
• Device Lot Number: 0360
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/30/2022
• Initial Date FDA Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1