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

Model Number 6842781

Device Problem False Negative Result (1225)

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

Event Date 04/26/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that discordant, false negative hiv combo (hivc) results were obtained when two different samples collected from a single donor (donor sample 1 and donor sample 2) and a weak reactive control 1 was tested using vitros hivc lot 0820 on a vitros 3600 immunodiagnostic system.The donor sample 1 result was discordant when compared to reactive vitros hivc result obtained using reagent lot 0790 for same patient sample.A definitive cause of the event could not be determined with the information provided.A sample related issue cannot be ruled out as contributing to the event.The customer stated the issue is isolated to the affected donor sample and other patient or donor samples were not affected.In addition, no testing using non-specific antibody blocking tubes was performed to identify a potential sample interferent, therefore, an unknown sample interferent cannot be ruled out as contributing to the event.In addition, the customer did not test either donor sample 1 or 2 with confirmatory testing, therefore, the true hiv status of the donor is unknown.A vitros hivc lot 0820 reagent performance issue did not likely contribute to the event as historic quality control results were acceptable, with the exception of the customer¿s weak reactive control 1, which is a control made in the laboratory by diluting the biorad virotrol hiv-1 ag, lot 114280 control.In addition, ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros hivc lots 0820 or 0830.There was no indication an instrument issue contributed to the event, as the customer did not indicate there were any performance issues with any additional vitros assays, however, as no diagnostic precision testing was conducted to verify instrument performance, an instrument issue cannot be completely ruled out as a contributor to the event.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report discordant, false negative hiv combo (hivc) results were obtained when two different samples collected from a single donor (donor sample 1 and donor sample 2) and a weak reactive control 1 was tested using vitros hivc lot 0820 on a vitros 3600 immunodiagnostic system.The donor sample 1 result was discordant when compared to reactive vitros hivc result obtained using reagent lot 0790 for same patient sample.Discordant, false negative hivc results were obtained when a second sample collected from the same donor (donor sample 2) was tested using vitros hivc lot 0830 on the same vitros 3600 immunodiagnostic system.Donor sample 1, vitros hivc lot 0820 results of 0.62, 0.70 and 0.89 s/c (negative) versus the lot 0790 reactive results.Customer¿s weak reactive control 1, vitros hivc lot 0820 results 0.37 and 0.87 s/c versus an expected reactive result.Donor sample 2, vitros hivc lot 0830 results of 0.34, 0.16 and 0.24 s/c (negative) versus the expected reactive results.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The vitros hivc discordant negative results obtained from the donor sample 1 and donor sample 2 were not reported outside the laboratory.The weak reactive control 1 was a non-patient sample and was not reported outside of the laboratory.There was no reported allegation of patient harm as a result of this event.This report is number two 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 numbers 400116385, 400119200 and reportability assessment 602011.

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS HIV COMBO 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: 17000582
• MDR Text Key: 315913261
• Report Number: 3007111389-2023-00077
• Device Sequence Number: 1
• Product Code: MZF
• UDI-Device Identifier: 10758750031580
• UDI-Public: 10758750031580
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/23/2023
• Device Model Number: 6842781
• Device Catalogue Number: 6842781
• Device Lot Number: 0820
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1