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

Catalog Number 6801325

Device Problem False Negative Result (1225)

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

Event Date 02/20/2023

Event Type  malfunction  

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report discordant, non-reactive vitros ahcv results were obtained when samples from multiple patients were tested on a vitros xt7600 integrated system.The results were discordant when compared to reactive non-vitros method results for the same patient samples.Vitros ahcv results: patient 6, vitros ahcv results of 0.68 and 0.70 s/c (non-reactive) vs the expected result of reactive patient 7, vitros ahcv result of 0.82 s/c (non-reactive) vs the expected result of reactive patient 9, vitros ahcv result of 0.79 s/c (non-reactive) vs the expected result of reactive patient 10, vitros ahcv results of 0.06 and 0.08 s/c (non-reactive) vs the expected result of reactive patient 11, vitros ahcv results of 0.02 and 0.04 s/c (non-reactive) vs the expected result of reactive patient 12, vitros ahcv results of 0.5 and 0.59 s/c (non-reactive) vs the expected result of reactive patient 13, vitros ahcv results of 0.68 and 0.70 s/c (non-reactive) vs the expected result of reactive biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The discordant, false non-reactive/negative vitros results were not reported from the laboratory as the patient samples were tested as part of the validation of a vitros instrument.Ortho has not been made aware of any allegation of patient harm as a result of this event.This report is number one of two mdr¿s 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).

Manufacturer Narrative

The investigation determined that discordant, non-reactive vitros ahcv results were obtained when samples from multiple patients were tested on a vitros xt7600 integrated system.The results were discordant when compared to reactive non-vitros method results for the same patient samples.A definitive cause of the event was not determined with the limited information provided.The discordant, non-reactive vitros results were obtained on a vitros xt7600 integrated system undergoing validation at the customer site and the vitros ahcv reagent assay had recently been put into use on the instrument, therefore, there were no historical qcs to verify the performance of the assay.However, qc results around the time of patient sample testing were acceptable, suggesting acceptable vitros ahcv lot 5320 performance.Additionally, ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros ahcv lot 5320.An instrument issue cannot be ruled out as a contributor to the event as there was no indication diagnostic precision testing had been conducted around the time the discordant, non-reactive vitros results were obtained.A potential cause of the event is the stability of the patient samples tested.The patient samples were tested following being stored at prolonged periods at -20°c and the ortho ls questioned the integrity of the patient samples tested.For certain samples, historical testing had occurred as far back as 2008.In addition, certain samples were turbid and turbid samples should not be used for vitros ahcv testing.The ortho tsc recommended further correlation testing to be conducted using patient samples within the stability as per the vitros instructions for use.

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV 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: 16572102
• MDR Text Key: 312285498
• Report Number: 3007111389-2023-00043
• Device Sequence Number: 1
• Product Code: MZO
• Combination Product (y/n): N
• Reporter Country Code: HR
• 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: 03/20/2023

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: 06/09/2023
• Device Catalogue Number: 6801325
• Device Lot Number: 5320
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2023
• Initial Date FDA Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1