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

Model Number 6801425

Device Problem False Positive Result (1227)

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

Event Date 02/24/2023

Event Type  malfunction  

Manufacturer Narrative

The customer reported that discordant reactive vitros anti-hbc igm (ahbcm) and anti-hav igm (ahavm) results obtained from two samples collected from the same patient compared to anti-hbc total and anti-hav total negative results were obtained from the same patient samples when tested on a vitros 3600 immunodiagnostic system.The assignable cause of the event is most likely an unknown sample interferent that affects the vitros ahavm and vitros ahbcm assays but not the vitros ahbc total and vitros ahav total assays.The customer performed a manual 20x dilution on sample 1, but did not program a 20x dilution factor and obtained vitros ahavm and ahbcm negative results.This indicates a potential sample interferent that was diluted out of the sample.The affected sample was sent to the mayo clinic to be tested with the anti-hbc total, anti-hav total, anti-hbc igm and anti-hav igm assays.The results obtained from the mayo clinic matched the vitros results obtained from the same four assays.However, it was determined the mayo clinic also used vitros assays.This supports the likelihood of an unknown sample interferent that affects the vitros ahavm and ahbcm assays but not the ahavt and ahbct assays.Historic quality control results were acceptable indicating vitros ahavm reagent lot 5730, ahavt reagent lot 5810, ahbcm reagent lot 8430 and ahbct reagent lot 8280 were performing as intended on the vitros 3600 immunodiagnostic system.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report discordant reactive vitros anti-hbc igm (ahbcm) and anti-hav igm (ahavm) results obtained from two samples collected from the same patient compared to anti-hbc total and anti-hav total negative results were obtained from the same patient samples when tested on a vitros 3600 immunodiagnostic system.Sample 1 vitros ahavm result of 10.4 s/c vs.A vitros ahav total negative result.Sample 1 vitros ahbcm result of 2.87 s/c vs.A vitros ahbc total negative result.Sample 2 vitros ahavm result of 10.4 s/c vs.A vitros ahav total negative result.Sample 2 vitros ahbcm result of 2.91 s/c vs.A vitros ahbc total negative result.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The vitros ahbcm and ahavm reactive results were reported outside the laboratory based on the concordant results obtained at the mayo clinic.There was no reported allegation of harm as a result of this event.This report is number one 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 numbers (b)(4) and reportability assessment (b)(4).

• 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: 16591918
• MDR Text Key: 311788515
• Report Number: 3007111389-2023-00047
• Device Sequence Number: 1
• Product Code: LOM
• UDI-Device Identifier: 10758750002795
• UDI-Public: 10758750002795
• 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: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2023
• Device Model Number: 6801425
• Device Catalogue Number: 6801425
• Device Lot Number: 8430
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1