MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-SARS-COV2 IGG REAGENT PACK; IN VITRO DIAGNOSTICS

Catalog Number 6199919

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

Patient Problem Test Result (2695)

Event Date 09/22/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The investigation determined that discordant, higher than expected vitros anti- sars-cov-2 igg results were obtained from a single patient sample processed using vitros cov2igg reagent lot 0185 on a vitros 3600 immunodiagnostic system and a vitros xt7600 integrated system.The vitros cov2igg results were higher than expected when compared to vitros cov2tot results and non-vitros anti-sars-cov-2 results for the patient.A definitive assignable cause for the discordant reactive vitros cov2igg results could not be determined.A vitros cov2igg lot 0185 reagent issue cannot be ruled out as a contributor to the event as there was no evidence that quality control fluids had been run around the time of the event.However, ongoing tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros cov2igg lot 0185.There was no evidence to suggest an instrument malfunction, however an instrument issue cannot be ruled out as a contributor to the event, as no precision testing was conducted to verify the performance of the vitros 3600 immunodiagnostic system or the vitros xt7600 integrated system around the time of the event.An interferent that affects the vitros cov2igg reagent assay cannot be ruled out as a contributor to the event, as no testing to rule out interference was conducted.In addition, pre-analytical sample processing could not be ruled out as a contributing factor as it was not determined whether the customer was following the sample collection device manufacturer¿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.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solutions centre (tsc) to report discordant, reactive vitros anti- sars-cov-2 igg (cov2igg) results obtained from a single patient sample when tested on a vitros 3600 immunodiagnostic system and a vitros xt7600 integrated system.The vitros cov2igg results were considered discordant when compared to non-reactive results from non-vitros cov2 methods.Vitros cov2igg results of 35 and 34.06 s/c (reactive) versus the expected result of non-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 reactive vitros cov2igg results for the patient were not reported from the laboratory.Patient management was not influenced based on the vitros result and ortho has not been made aware of any allegation of patient harm as a result of this event.This report is number 1 of 2 mdr¿s for this event.Two (2) 3500a forms are being submitted for this event as 2 devices were involved.This report corresponds to ortho clinical diagnostics inc.Complaint numbers (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-SARS-COV2 IGG 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: 10706690
• MDR Text Key: 213723214
• Report Number: 3007111389-2020-00160
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/27/2020
• Device Catalogue Number: 6199919
• Device Lot Number: 0185
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2020
• 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