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 06/17/2023

Event Type  malfunction  

Event Description

The investigation determined that false negative vitros anti-hiv 1 & 2 (ahiv1+2) results were obtained from two different lots of vitros ahiv1+2 reagent when testing using a non-vitros biorad quality control (qc) fluid on two different vitros 5600 integrated systems.Vitros anti-hiv 1 & 2 lot 1110: virotrol i: vitros ahiv1+2 on inst j1 of 0.58, 0.60, 0.57, 0.62, 0.60, 0.58, 0.61, 0.58, 0.57 and 0.57 s/c (negative) versus the expected result of reactive (>/=1.00) virotrol i: vitros ahiv1+2 on inst j2 of 0.42, 0.44, 0.53, 0.15, 0.15, 0.15, 0.57 and 0.31 s/c (negative) versus the expected result of reactive (>/=1.00) vitros anti-hiv 1 & 2 lot 1100: virotrol ii: vitros ahiv1+2 on inst j2 of 0.44, 0.43 and 0.44 s/c (negative) versus the expected result of reactive (>/=1.00) biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The false negative results occurred only of quality control fluids.The customer processed patient testing using vitros hiv1+2 lot 1100 and there was no allegation of patient harm.The customer did not use the vitros hiv1+2 lot 1110 reagent lot to run patient samples because of the issue with the virotrol qc results.There was no allegation of patient harm as a result of this event.This report is number one of four mdr¿s for this event.Four 3500a forms are being submitted for this event as four devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint numbers (b)(4) and reportability assessment (b)(4).

Manufacturer Narrative

The investigation determined that false negative vitros anti-hiv 1 & 2 (ahiv1+2) results were obtained from two different lots of vitros ahiv1+2 reagent when testing using a non-vitros biorad quality control (qc) fluid on two different vitros 5600 integrated systems.A definitive assignable cause could not be determined with the information provided.No information was provided on pre analytical qc fluid handling, therefore, it is possible improper handling of the vitros ahiv1+2 qc samples during testing events contributed to the discordant, reactive vitros ahiv1+2 results, although this cannot be confirmed.In addition, pre-analytical sample mix up is a potential contributor as the customer had 5 different virotrol qc fluids for various assays.The unacceptable results obtained using vitros ahiv1+2 reagent lot 1100 occurred on only one of the two vitros analyzers.The overall qc performance obtained around the time of the event using vitros ahiv1+2 reagent lot 1100 was acceptable on both vitros analyzers with the exception of the three false negative results.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros ahiv1+2 lot 1100.The unacceptable qc results obtained using vitros ahiv1+2 reagent lot 1110 occurred on both vitros analyzers and was consistent from the time the lot was calibrated.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros ahiv1+2 lot 1100.The customer declined further investigation as they were taking the vitros 5600 analyzers out of service and installing new vitros xt 7600 analyzer.The customer planned to discontinue using the vitros ahiv1+2 assay and move to the vitros hiv combo assay on the new analyzers.Therefore, the assignable cause could not be determined.An ortho field engineer did perform service actions to the subsystems that process microwell testing on both vitros analyzers.However, an instrument performance issue could not be confirmed or ruled out as a potential contributor to the event as no diagnostic within run precision testing was performed prior to service actions and unacceptable qc was obtained following service actions.

• 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: 17451521
• MDR Text Key: 320343445
• Report Number: 3007111389-2023-00126
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/08/2023
• Device Catalogue Number: 6801861
• Device Lot Number: 1100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1