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

Catalog Number	6801925
Medical Device Problem Codes	False Positive Result (1227); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined a non-reproducible, discordant positive vitros anti-hbs (ahbs) result was obtained from a single patient sample tested on a vitros 5600 integrated system.The vitros ahbs positive result generated from reagent lot 9030 was discordant when compared to multiple vitros ahbs negative results obtained from the same sample using an alternate vitros ahbs reagent, lot 9050.The assignable cause of the event is unknown.It is unknown if the customer is following the sample collection device manufacture's recommendation for sample centrifugation and improper pre-analytical sample processing cannot be ruled out as contributing to the event.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.Based on historic acceptable quality control results generated from reagent lot 9030, there is no indication vitros ahbs reagent lot 9030 contributed to the event.However, an investigation by ortho determined there was a stability issue with vitros ahbs calibrator lot 9030 where signal reduction over the shelf life of the product potentially leading to positively biased patient and/or quality control (qc) results.Since vitros microwell calibrators and reagent are lot-linked, a performance issue with the calibrator will affect reagent performance.However, a review of calibration signals from four calibration events over a three-month timeframe remained consistent, which would indicate the issue described in (b)(4) did not likely occur.A performance issue with the vitros 5600 integrated system cannot be ruled out as contributing to the event.The customer reported addition examples of imprecision with replicate results obtained from two alternate patient samples using an alternate vitros ahbs reagent lot (lot 9050) that did not meet the criteria for reportable event.In addition, the customer also reported false reactive results on another assay that did not meet the criteria for a reportable event.An ortho field engineer (fe) went on site on two different occasions and replaced the sample metering pump, the inner and outer microwell incubator heater ring plates, inner and outer incubator rings, the inner incubator ring motor, the microwell incubator shuttle, the signal reagent dispense tip, the well shuttle weight, the well wash aspirate filter, the gasket puffer and performed all necessary adjustments.The ortho fe also cleaned the microwell incubator.The service actions performed are expected to resolve the imprecision issue.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a non-reproducible, discordant positive vitros anti-hbs (ahbs) result was obtained from a single patient sample tested on a vitros 5600 integrated system.The vitros ahbs positive result generated from reagent lot 9030 was discordant when compared to multiple vitros ahbs negative results obtained from the same sample using an alternate vitros ahbs reagent, lot 9050.Vitros ahbs result of positive (52.0 miu/ml) vs.The expected result of negative biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The discordant positive vitros ahbs result was obtained for pre-employment screen of a new hire.The discordant positive vitros ahbs result was removed from the employees records and a ahbs negative result was documented.There was no 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 (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK
• Common Device Name: 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 ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 19510592
• Report Number: 3007111389-2024-00113
• Device Sequence Number: 19721408
• Product Code: LOM
• UDI-Device Identifier: 10758750001682
• UDI-Public: 10758750001682
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/10/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/26/2024
• Device Catalogue Number: 6801925
• Device Lot Number: 9030
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown