MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS BENZ REAGENT; IN-VITRO DIAGNOSTICS

Catalog Number	6801989
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that false negative vitros benzodiazepine (benz) results were obtained from samples from two different patients processed using vitros chemistry products benz reagent lot 1523-67-2046 in combination with a vitros xt 7600 integrated system.The results were considered false negative when compared to results using the same samples from confirmatory testing using gc/ms and an unknown reference method.The assignable cause is a known limitation of the vitros benz reagent related to low cross reactivity with lorazepam glucuronide.Per the vitros benz instruction for use (ifu) specificity (cross reactivity) tables, at the 200 ng/ml cutoff, vitros benz reagent has a 34% cross reactivity with lorazepam.Continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros benz reagent lot 1523.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report false negative vitros benzodiazepine (benz) results were obtained from samples from two different patients processed using vitros chemistry products benz reagent lot 1523-67-2046 in combination with a vitros xt 7600 integrated system.The results were considered to be false negatives when compared to results using the same samples from confirmatory testing using gc/ms and an unknown reference method.Patient 1 sample result of 143 ng/ml (negative) vs an expected result of positive patient 2 sample result of 129 ng/ml (negative) vs an expected result of positive biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The false negative vitros benz results were not reported outside of the laboratory.There was no reported allegation of patient harm as a result of this event.This report is number one of two mdrs for this event.Two 3500a forms are being submitted for this event as two devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS BENZ REAGENT
• 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, INC.; 1000 lee road; rochester NY 14606
• Manufacturer Contact: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 20639756
• Report Number: 1319808-2024-00040
• Device Sequence Number: 12618117
• Product Code: JXM
• UDI-Device Identifier: 10758750001750
• UDI-Public: (01)10758750001750(17)241229(11)230929(10)672046
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/08/2024

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: 12/29/2024
• Device Catalogue Number: 6801989
• Device Lot Number: 1523-67-2046
• 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: 10/16/2024
• Initial Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2023
• 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