MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HIV 1+2 REAGENT PACK; IN-VITRO DIAGNOSTICS

Catalog Number 6801861

Device Problem False Negative Result (1225)

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

Event Date 12/15/2023

Event Type  malfunction  

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report discordant, negative vitros anti-hiv 1 + 2 (ahiv) results were obtained from positive non-vitros fluids supplied by the provincial center for disease control when tested on a vitros 5600 integrated system, when compared to reactive ahiv results obtained using three different non-vitros systems.Sample 1 result of 0.24 s/c (negative) versus the expected result of reactive sample 3 result of 0.29 s/c (negative) versus the expected result of reactive sample 4 result of 0.24 s/c (negative) versus 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 customer made no indication that patient sample results were affected.However, given that the vitros results were discordant to three non-vitros methods and only very limited qc fluid information was provided to verify the operation of the reagent, ortho cannot definitively rule out that patient results would not be affected if the event were to recur undetected.There were no allegations of harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number 400157937 and reportability assessment 604663.

Manufacturer Narrative

The investigation has determined discordant, negative vitros anti-hiv 1 + 2 (ahiv) results were obtained from positive non-vitros fluids supplied by the provincial center for disease control when tested on a vitros 5600 integrated system, when compared to reactive ahiv results obtained using three different non-vitros systems.A definitive assignable cause could not be determined.Only minimal qc fluid information was provided by the customer; therefore, the performance of the reagent could not be fully verified, and a reagent issue cannot be ruled out as contributing to this event.Precision testing of the vitros 5600 integrated system was not performed when requested, therefore it cannot be confirmed that the instrument was operating as intended and unexpected instrument performance cannot be completely ruled out as contributing to the event.A possible cause for the lower than expected, discordant vitros ahiv results is an issue with the non-vitros provincial center for disease control fluids used by the customer.The samples were established to have been of a non-serum matrix.Control materials may show a difference when compared with other ahiv 1+2 methods if they contain high concentrations of preservatives, stabilizers, or other nonphysiological additives, or otherwise depart from a true human sample matrix.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros ahiv reagent lot 4320.

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HIV 1+2 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: 18518499
• MDR Text Key: 333541898
• Report Number: 3007111389-2024-00008
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6801861
• Device Lot Number: 4320
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1