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 03/22/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation determined a false, negative result was obtained from a single patient sample processed using vitros immunodiagnostics products anti-hiv 1 + 2 (ahiv1+2) reagent on a vitros 5600 integrated system.The assignable cause of the event was not determined with the limited information provided.The patient¿s sample was sent for repeat anti-hiv screening on a second vitros system however, the information on the vitros system used and the patient¿s sample results have not been provided.The sample was also sent for further anti-hiv testing on an abbott i2000 system and it is unknown if a positive result was obtained.Based on qc results obtained around the time of the event, a vitros ahiv1+2 reagent lot 4230 performance issue is not a likely contributor to the event.Additionally, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros ahiv1+2 lot 4230.Instrument related performance issues did not likely contribute to the events as the customer gave no indication of any instrument malfunction however, as no diagnostic within run precision testing was performed, an instrument issue cannot be completely ruled out as a potential contributor to the event.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a false, negative result was obtained from a single patient sample processed using vitros immunodiagnostics products anti-hiv 1 + 2 (ahiv1+2) reagent on a vitros 5600 integrated system.Vitros ahiv1+2 = negative (0.08 s/c) versus expected positive (6.45 s/c).Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The false negative anti-hiv1+2 patient result was not reported from the laboratory.Ortho has not been made aware of any allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment 601479.

• 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: 16781643
• MDR Text Key: 314051518
• Report Number: 3007111389-2023-00060
• Device Sequence Number: 1
• Product Code: MZF
• UDI-Device Identifier: 00758750001521
• UDI-Public: 0758750001521
• 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: 04/20/2023

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: 05/24/2023
• Device Catalogue Number: 6801861
• Device Lot Number: 4230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2023
• Initial Date FDA Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1