MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS 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 01/20/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a discordant, false negative hivc result was obtained when a sample from a single patient was tested using vitros hivc lot 0761 on a vitros 3600 immunodiagnostic system.The 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 vitros hivc lot 0761 reagent performance issue did not likely contribute to the event as historic quality control results were acceptable.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 lot 0761.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.In addition, pre-analytical sample handling could not be ruled out as a contributing factor as the affected patient sample was stored frozen between test events and it is unknown if the sample was mixed by inversion several times prior to the retest event when the discordant negative vitros hivc result was obtained.The analytes contained in a sample can concentrate in the bottom of the sample container when frozen, therefore, if the samples were not well mixed prior to testing, it is possible that hiv antigen or antibody concentration in the samples would be falsely lower than expected.In addition, the customer did not verify the vitros hivc discordant negative result by retesting with the either the vitros method or on a non-vitros method.The customer does not have indices turned on in the vitros 3600 immunodiagnostics system, therefore, it is not possible to determine if there was a change in indices between the initial and retest event for the patient 1 sample, therefore, it is not possible to rule out or confirm pre-analytical sample mix-up as causing the event.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a discordant, false negative hivc result was obtained when a sample from a single patient was tested using vitros hivc lot 0761 on a vitros 3600 immunodiagnostic system.The result was discordant when compared to reactive vitros hivc result obtained using reagent lot 0790 for same patient sample.Patient 1 sample, vitros hivc lot 0761 result of 0.18 s/c (negative) versus the lot 0790 result of 1.09 s/c (reactive) 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 result obtained from the patient 1 sample was not reported outside the laboratory and there was no reported 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 (b)(4).

• Brand Name: VITROS 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: 16430499
• MDR Text Key: 310177895
• Report Number: 3007111389-2023-00027
• 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: 02/23/2023

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: 04/20/2023
• Device Model Number: 6842781
• Device Catalogue Number: 6842781
• Device Lot Number: 0761
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2023
• Initial Date FDA Received: 02/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1