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

Catalog Number 6801322

Device Problem False Negative Result (1225)

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

Event Date 09/14/2023

Event Type  malfunction  

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report false negative vitros hbsag results were obtained when tested using non-vitros external quality assessment (eqa) proficiency fluids when using vitros hbsag reagent lot 3460 on a vitros 3600 immunodiagnostic system.Eqa sample 231h-12 results of 0.07 and 0.08 (non-reactive) s/c vs.Expected result of 2.23 and 2.35 s/c (reactive).Eqa sample 231h-16 results of 0.19 and 0.18 (non-reactive) s/c vs.Expected result of 1.69 and 1.78 s/c(reactive).Eqa sample 231h-20 results of 0.57 and 0.60 (non-reactive) s/c vs.Expected result of 3.58 and 3.78 s/c (reactive).Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The false negative vitros hbsag results were obtained from a non-patient fluid.The customer did not indicate that any unexpected vitros hbsag results were obtained for patient samples at the time of the event or over the course of the investigation and there are no reported allegations of patient harm.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment (b)(4).

Manufacturer Narrative

The investigation determined that false negative vitros hbsag results were obtained when tested using non-vitros external quality assessment (eqa) proficiency fluids when using vitros hbsag reagent lot 3460 on a vitros 3600 immunodiagnostic system.A definite assignable cause of the event cannot be determined.A potential contributor to the event was the calibration in use.A review of vitros hbsag reagent lot 3460 calibrations identified that the false negative vitros hbsag results were processed on a calibration that had expired 2 months prior.No precision testing was performed on the vitros 3600 immunodiagnostic system at the time of the event; therefore, an instrument related issue cannot be entirely ruled out as a contributor of the events.However, historical vitros qc fluid results were precise, and no evidence of any instrument malfunction was reported.The proficiency samples were from blood bags.Sample handling and storage of the proficiency samples is a possible contributor to the event as it was not determined if the customer was following the eqa ifu recommendation for sample handling and storage.Furthermore, the presence of an unknown sample interferent that affects the vitros hbsag method and not the non-vitros hbsag method cannot be ruled out as contributing to this event.The vitros hbsag ifu states ¿a negative test result does not exclude the possibility of exposure to or infection with hepatitis b virus.Levels of hbsag may be undetectable both in early infection and late after infection.In rare cases hbsag tests do not detect certain hbv mutant strains.

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG 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: 18104573
• MDR Text Key: 329329014
• Report Number: 3007111389-2023-00196
• Device Sequence Number: 1
• Product Code: LOM
• UDI-Device Identifier: 10758750001064
• UDI-Public: 10758750001064
• Combination Product (y/n): N
• Reporter Country Code: VM
• 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: 11/09/2023

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: 01/24/2024
• Device Catalogue Number: 6801322
• Device Lot Number: 3460
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2023
• Initial Date FDA Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1