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

Catalog Number 6801322

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/31/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that discordant negative vitros (b)(6) results were obtained from a single patient sample.The results were considered discordant compared to positive (b)(6) results obtained from non-vitros methods.A definitive cause of the discordant vitros results was not established.However, a sample related issue likely contributed to the event.It is possible that a mutant (b)(6) strain not detected by the vitros reagent assays was present in the patient sample.The vitros (b)(6) ifu states that in rare cases (b)(6) tests do not detect certain hbv mutant strains.Based on historical quality control results, a vitros (b)(6) lot 8525 performance issue is not a likely contributor to 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 (b)(6) lot 8525.There was no indication that the vitros 3600 immunodiagnostic system malfunctioned.However, as no precision testing was conducted around the time of the event to verify instrument performance, an instrument issue cannot be ruled out as a contributor to the event.In addition, ortho was unable to determine whether the customer was following the sample collection device manufacturer¿s recommendations for sample centrifugation, therefore inappropriate pre-analytical sample handling could not be completely ruled out as contributing to the discordant results.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solutions center (tsc) to report discordant negative results obtained from a patient sample using vitros immunodiagnostic products (b)(6) reagent on a vitros 3600 immunodiagnostic system.Vitros (b)(6) results of 0.13 and 0.13 s/c (non-reactive) versus the expected result of 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 discordant negative vitros (b)(6) results were reported from the laboratory.The clinician was aware of the patient's active disease status and requested additional testing.A corrected report was later issued.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.(b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK
• Type of Device: IN VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO CLINICAL DIAGNOSTICS; felindre meadows; pencoed; bridgend, wales CF35 5PZ; UK CF35 5PZ
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 9777462
• MDR Text Key: 224676119
• Report Number: 3007111389-2020-00022
• Device Sequence Number: 1
• Product Code: LOM
• 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
• Type of Report: Initial
• Report Date: 03/02/2020

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: 04/16/2020
• Device Catalogue Number: 6801322
• Device Lot Number: 8525
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/03/2020
• Initial Date FDA Received: 03/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1