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 Measurement (1383)

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

Event Date 07/27/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that discordant vitros anti- sars-cov-2 igg results were obtained from two different patient samples when processed using vitros cov2igg reagent lot 0160 on two different vitros xt7600 integrated systems.A definitive assignable cause for the discordant reactive results could not be determined with the information provided.Based on historical quality control results, a vitros cov2igg reagent performance issue is not a likely contributor to the event as all qc fluid results were within the correct ifu interpretation region.Additionally, there is no indication of an instrument malfunction and unexpected instrument performance is not a likely contributor to the event.However, it cannot be entirely ruled out as a contributing factor as precision testing to assess instrument performance was not performed by the customer when requested.In addition, pre-analytical sample processing could not be ruled out as a contributing factor, as it was established that the customer was not following the sample collection device manufacturers recommendation for sample centrifugation and cellular debris, due to poor sample preparation, was likely present in the affected sample, although this could not be confirmed.The most likely cause of the discordant results in this case is the vitros cov2igg test generated false positive results for the samples under test.The vitros cov2igg ifu does not preclude the possibility of false positive cov2igg results due to cross-reactivity from pre-existing antibodies or other possible causes.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros cov2igg lot 0160.

Event Description

An ortho clinical diagnostics (ortho) laboratory specialist (ls) contacted the ortho technical solutions centre (tsc) on behalf of a customer to report discordant reactive vitros anti- sars-cov-2 igg (cov2igg) results obtained from samples drawn from two different patients when tested on two different vitros xt7600 integrated systems.The vitros cov2igg results were considered discordant as non-reactive results were obtained for the same sample tested using a vitros anti- sars-cov-2 total (cov2tot) method.Patient 1 result of 1.37 and 1.16 s/c (reactive) versus the expected result of non-reactive.Patient 2 result of 1.26 and 1.20 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.It was unknown if the discordant vitros cov2igg results were reported from the laboratory to a physician.Ortho is not aware of any allegation of patient harm as a result of this event.This report is number 1 of 2 mdrs 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: 10454433
• MDR Text Key: 242745148
• Report Number: 3007111389-2020-00110
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: RP
• 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: 08/26/2020

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: 11/18/2020
• Device Catalogue Number: 6199919
• Device Lot Number: 0160
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/03/2020
• Initial Date FDA Received: 08/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2020
• 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