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

Model Number 6192255

Device Problem High Test Results (2457)

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

Event Date 06/03/2023

Event Type  malfunction  

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher than expected vitros nt pro-bnp ii results were obtained from non-vitros biorad qc fluids and numerous patient samples using vitros immunodiagnostics products nt pro-bnp ii reagent lots 0091, 0125 and 0130 in combination with a vitros 5600 integrated system.Vitros nbnp2 lot 0091 results: biorad level 1 quality control results of 1574, 1573, 1574, 1576, 1572, 1576 and 1575 pg/ml vs.Expected result of 50.6 pg/ml.Biorad level 3 quality control results of 4161, 4067, 4145, 4104 and 4096 pg/ml vs.Expected result of 2830 pg/ml.Patient 2 result of 1560 pg/ml vs.Expected result of 38 pg/ml.Patient 3 result of 1770 pg/ml vs.Expected result of 253 pg/ml.Patient 5 result of 1630 pg/ml vs.Expected result of 106 pg/ml.Patient 7 result of 2260 pg/ml vs.Expected result of 710 pg/ml.Patient 8 result of 1560 pg/ml vs.Expected result of 39 pg/ml.Vitros nbnp2 lot 0125 results: biorad level 1 quality control results of 1573 pg/ml vs.Expected result of 50.6 pg/ml.Biorad level 3 quality control results of 4073 pg/ml vs.Expected result of 2830 pg/ml.Vitros nbnp2 lot 0130 results: biorad level 1 quality control results of 1569 pg/ml vs.Expected result of 50.6 pg/ml.Biorad level 3 quality control results of 4125 pg/ml vs.Expected result of 2830 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 nt pro-bnp ii quality control results were from non-patient fluids and were not reported from the laboratory.However, patient samples were processed when the qc fluids were out of range and results for these samples were reported from the laboratory.Corrected reports were later issued for the samples reported and ortho has not been made aware of any treatment administered, altered or stopped based on the reported results.Ortho has not been made aware of any allegation of patient harm as a result of this event.This report is number three of three mdr¿s for this event.Three 3500a forms are being submitted for this event as three devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4), (b)(4), (b)(4) and reportability assessment (b)(4).

Manufacturer Narrative

The investigation determined that higher than expected vitros nt pro-bnp ii results were obtained from non-vitros biorad qc fluids and numerous patient samples using vitros immunodiagnostics products nt pro-bnp ii reagent lots 0091, 0125 and 0130 in combination with a vitros 5600 integrated system.The cause of the higher than expected biorad qc fluid results and patient sample results has been established to be user error.At some point between 01 june 2023 and 02 june 2023 the customer altered the slope and intercept parameters causing the significant bias in vitros nbnp2 results obtained until the slope and intercept parameters were reset to default settings on (b)(6) 2023.There is no indication that the vitros 5600 integrated system or the vitros nbnp2 reagents malfunctioned in any way as all other biorad qc fluids tested were performing acceptably and patient samples predicted as expected when the slope and intercept parameters were set at default levels.

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS NT PROBNP 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: 17219456
• MDR Text Key: 318049798
• Report Number: 3007111389-2023-00110
• Device Sequence Number: 1
• Product Code: NBC
• UDI-Device Identifier: 10758750033300
• UDI-Public: 10758750033300
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/28/2023

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: 10/12/2023
• Device Model Number: 6192255
• Device Catalogue Number: 6192255
• Device Lot Number: 0125
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/04/2023
• Initial Date FDA Received: 06/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1