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

Catalog Number 6199922

Device Problem False Negative Result (1225)

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

Event Date 10/30/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a discordant negative vitros anti- sars-cov-2 total results were obtained from three patient samples processed using vitros cov2tot reagent lot 0220 on a vitros 3600 immunodiagnostic system.An assignable cause was not determined.The patients had all previously tested pcr positive approximately 2-4 weeks prior to vitros testing.It would be expected that the vitros cov2tot would be reactive as this assay detects the presence of igm, iga, and igg antibodies.No additional testing was performed to confirm or rule out the presence of an interferent in these patient samples.A review of historical quality control results for vitros cov2tot lot 0220 indicates acceptable performance and a reagent 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 cov2tot reagent lots 0220.Unexpected instrument performance is not a likely contributor to the events.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.The customer provided no information concerning the sample collection device used to collect the affected samples or sample processing of the affected samples.Therefore, pre-analytical sample handling cannot be ruled out as a potential contributor to this event.(b)(4).

Event Description

The customer reported that discordant negative vitros anti- sars-cov-2 total results were obtained from three patient samples processed using vitros cov2tot reagent lot 0220 on a vitros 3600 immunodiagnostic system.Patient 1 vitros cov2tot = 0.45 s/c (non-reactive) versus expected reactive.Patient 2 vitros cov2tot = 0.74 s/c (non-reactive) versus expected reactive.Patient 3 vitros cov2tot = 0.07 s/c (non-reactive) versus expected reactive.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The vitros results were not used for diagnostic purposes but patients were monitored for a period after a positive pcr result.There was no known treatment information for these patients.Ortho was not made aware of any allegation of patient harm as a result of this event.This report is number 1 of 3 mdr¿s for this event.Three (3) 3500a forms are being submitted for this event as three devices were involved.This report corresponds to ortho clinical diagnostics inc.Complaint numbers (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-SARS-COV2 TOTAL REAGENT
• 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: joseph falvo ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 11002452
• MDR Text Key: 221888862
• Report Number: 3007111389-2020-00204
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: RO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/03/2021
• Device Catalogue Number: 6199922
• Device Lot Number: 0220
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2020
• 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