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

Catalog Number 6842781

Device Problem False Positive Result (1227)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/05/2022

Event Type  malfunction  

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report discordant, false reactive hivc results obtained when samples from a single patient were tested using vitros hivc lot 0410 and lot 0450 on two different vitros xt7600 integrated systems.The results were discordant when compared to negative western blot hiv results for same patient samples.Patient 1, sample 1, vitros hivc lot 0410 result of 1.92 s/c (reactive) versus a western blot result of negative.Patient 1, sample 2, vitros hivc lot 0450 result of 1.39 s/c (reactive) versus a western blot result of negative.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The false reactive vitros hivc results for patient 1 were reported from the laboratory.Treatment was altered/initiated for patient 1 due to the false reactive vitros hivc results, as a c-section was performed on the patient rather than a natural birth.As per the medical consultation with an ortho medical safety officer: ¿based on the available information, the affected patient did not experience serious adverse event via the c-section procedure and her condition was stable.However, due to the potential risk for subsequent births, this case is classified as a serious injury¿.The condition of patient 1 upon follow up was stable.Ortho has not been made aware of any 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 number 2474381, 2479691 and ivd 514549.

Manufacturer Narrative

The investigation determined that discordant, false reactive hivc results were obtained when samples from a single patient were tested using vitros hivc lot 0410 and lot 0450 on two different vitros xt7600 integrated systems.The results were discordant when compared to negative western blot hiv results for same patient samples.A definitive cause of the event could not be determined with the information provided.A vitros hivc lot 0410 or lot 0450 reagent issue cannot be ruled out as no qc results were provided, therefore it was not possible to verify the performance of the vitros hivc reagent assays.However, the vitros hivc results for the patient were concordant between lot 0410 and lot 0450 and ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros hivc lot 0410 or lot 0450.It is unlikely instrument issues contributed to the event, as the vitros hivc results were concordant between two vitros instruments.However, as no diagnostic precision testing was conducted to verify instrument performance, instrument issues cannot be completely ruled out as a contributor to the event.It is possible an interferent that affects the vitros hivc method and not the western blot method contributed to the false reactive results for the patient, however, this could not be confirmed as no further investigational testing was conducted to rule out a sample interferent present in the samples drawn from patient 1.In addition, pre-analytical sample processing could not be ruled out as a contributing factor as it was not determined whether the customer was following the sample collection device manufacture¿s recommendation for sample centrifugation.Improper pre-analytical sample handling could have contributed to this event.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.Email address for contact office in above is (b)(6).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS HIV COMBO REAGENT PACK
• Type of Device: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO CLINICAL DIAGNOSTICS; felindre meadows; pencoed; bridgend, wales CF35 5PZ; UK CF35 5PZ
• Manufacturer Contact: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 15740859
• MDR Text Key: 308028308
• Report Number: 3007111389-2022-00201
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/10/2023
• Device Catalogue Number: 6842781
• Device Lot Number: 0450
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1