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

Catalog Number 6801425

Device Problem False Positive Result (1227)

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

Event Date 09/29/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that discordant, reactive vitros anti-hbc igm (ahbcm) results were obtained from a single patient sample when tested using vitros ahbcm lot 2090 on a vitros eci q immunodiagnostic system.The results were not in agreement with results from alternate vitros hepatitis b testing for the same samples for the patient.A definitive cause of the event was not established.There was limited historical qc data available to assess reagent performance, as vitros ahbcm lot 2090 had only recently been put into put into use on the instrument.However, qc results on the date the false reactive results were obtained for patient 1 were acceptable on the date of the event.Additionally, ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros ahbcm lot 2090.It is possible the suboptimal calibration caused the vitros ahbcm results for patient 1 to shift high into the reactive interpretation for the assay, however, this could not be confirmed.In addition, the cause of the suboptimal calibration was not determined.There was no evidence of an instrument malfunction, however, as no diagnostic precision testing was conducted to verify the performance of the vitros eci q immunodiagnostic system, instrument related issues cannot be ruled out as a contributor to the event.However, the vitros ahbcm results for two separate samples for patient 1 (sample 1 and sample 2) from testing on the vitros eci q immunodiagnostic system were concordant, therefore instrument related issues did not likely cause the discordant, reactive vitros ahbcm results for patient 1.Pre-analytical sample processing could not be ruled out as a contributing factor as it was not possible to determine if 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.It is possible an interferent that affects the vitros ahbcm method contributed to the event.There was no sample remaining from patient 1 to conduct further investigational testing.Therefore, interference in the sample from patient 1 cannot be ruled out as a contributor to the event.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report discordant, reactive vitros anti-hbc igm (ahbcm) results were obtained from a single patient sample when tested using vitros ahbcm lot 2090 on a vitros eci q immunodiagnostic system.The results were not in agreement with results from alternate vitros hepatitis b testing for the same samples for the patient.Patient 1, vitros ahbcm results of 3.13 and 3.24 s/c (reactive) versus the expected result of < 0.80 s/c (non-reactive) biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The discordant, reactive vitros ahbcm results were 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 603634.

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM 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: 18009545
• MDR Text Key: 326587431
• Report Number: 3007111389-2023-00189
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 10/25/2023

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: 05/27/2024
• Device Catalogue Number: 6801425
• Device Lot Number: 2090
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2023
• Initial Date FDA Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1