MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-SARS-COV-2 IGG REAGENT PACK; IN-VITRO DIAGNOSTIC

Catalog Number 6199919

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

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

Event Date 02/13/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a discordant, reactive vitros anti- sars-cov-2 igg (cov2igg) result was obtained from a single patient sample processed using vitros cov2igg reagent lot 0280 on a vitros xt 7600 integrated system.The vitros cov2igg result was discordant when compared to a non-reactive vitros anti- sars-cov-2 total (cov2tot) result from the same patient sample.A definitive assignable cause for the event was not established.Based on historical qc results, a vitros cov2igg reagent performance issue is not a likely contributor to the event as qc fluid results were within the correct ifu interpretation region leading up to the event.Additionally, ongoing tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros cov2igg lot 0280.An instrument issue cannot be ruled out as a contributor to the event, as no diagnostic precision testing was conducted to verify the performance of the vitros xt7600 integrated system.It was not possible to establish whether 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.Interference from a non-specific antibody cannot be ruled out as a contributor to the event, as no testing to rule out an interferent was not conducted on the sample from the patient when requested.It is possible that an interferent that affected the vitros cov2igg reagent assay and not the vitros cov2tot reagent assay contributed to the event, but this could not be confirmed.A definitive assignable cause of the event was not determined.(b)(4).

Event Description

A customer obtained a discordant, reactive vitros anti- sars-cov-2 igg (cov2igg) result from a single patient sample processed using vitros cov2igg reagent lot 0280 on a vitros xt 7600 integrated system.The vitros cov2igg result was discordant when compared to a non-reactive vitros anti- sars-cov-2 total (cov2tot) result from the same patient sample.Patient 1, vitros cov2igg result of 1.28 s/c (reactive) versus the vitros cov2tot result of 0.36 s/c (non-reactive).Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected.The reactive vitros cov2igg result was not reported from the laboratory.Ortho has not been made aware any allegation of actual patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho).Complaint number (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-SARS-COV-2 IGG REAGENT PACK
• Type of Device: IN-VITRO DIAGNOSTIC
• 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: laurie o'riordan ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 11448698
• MDR Text Key: 240786552
• Report Number: 3007111389-2021-00033
• Device Sequence Number: 1
• Product Code: QKO
• 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: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 6199919
• Device Lot Number: 0280
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2020
• 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