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

Catalog Number 6192255

Device Problem Low Test Results (2458)

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

Event Date 07/07/2023

Event Type  malfunction  

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a lower than expected vitros nbnp2 result was obtained when a spanish preanalytical quality monitoring program (seqc) proficiency sample was tested using vitros nbnp2 lot 0610 on a vitros xt7600 integrated system.Seqc july 2023 sample result of 164.06 pg/ml versus the mean result of 322 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 as when the customer was processing a non-patient sample.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 (b)(4).

Manufacturer Narrative

The investigation determined that a lower than expected vitros nbnp2 result was obtained when a spanish preanalytical quality monitoring program (seqc) proficiency sample was tested using vitros nbnp2 lot 0610 on a vitros xt7600 integrated system.A definitive assignable cause of the event was not determined.Vitros nbnp2 lot 0610 was only recently put into use on the customer¿s instrument, therefore there were limited qc results to verify historical vitros nbnp2 lot 0610 performance.Additionally, the customer had only processed one of the three levels of controls leading up to the event, meaning the performance of vitros nbnp2 lot 0610 throughout its measuring range was not verified.Therefore, a vitros nbnp2 reagent issue cannot be ruled out as a contributor to the event.However, the qcs processed leading up to the event were acceptable and ongoing tracking and trending of complaint data did not identify any signals to suggest there is a systemic quality issue with vitros nbnp2 lot 0610.An instrument issue cannot be ruled out as a contributor to the event, as no diagnostic precision testing was conducted to verify the performance of the vitros xt7600 integrated system.Improper handling of the seqc proficiency sample cannot be ruled out as a contributor to the event, as no information was provided on how the customer prepared the seqc proficiency sample or the correct handling protocol for the proficiency sample.It is possible the mean result of the seqc sample (322 pg/ml) was a value comprised of vitros nt-probnp results and vitros nbnp2 results and therefore an inaccurate target value, however, this could not be confirmed.

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS NT-PROBNP II REAGENT PACK
• Type of Device: 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: 17735742
• MDR Text Key: 323270940
• Report Number: 3007111389-2023-00157
• Device Sequence Number: 1
• Product Code: NBC
• UDI-Device Identifier: 10758750033300
• UDI-Public: 10758750033300
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 09/12/2023

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: 10/02/2023
• Device Catalogue Number: 6192255
• Device Lot Number: 0610
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2023
• Initial Date FDA Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1