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

Catalog Number 6199922

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/13/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that non-reactive vitros anti-sars-cov-2 total (cov2tot) results were obtained from a single patient sample processed using vitros cov2tot lot 0021 on a vitros 5600 integrated system.A definitive assignable cause for the discordant non-reactive results could not be determined with the information provided.Based on historical quality control results, a vitros cov2tot reagent performance issue is not a likely contributor to the event as all vitros quality control (qc) fluid results were within the correct ifu interpretation region.Additionally, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros cov2tot lot 0021.There is also 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.In addition, it was established the customer is following the sample collection device manufacturer¿s recommended centrifugation protocol; therefore, pre-analytical sample processing can be ruled out as a contributing factor.A definitive cause of the event was not determined.

Event Description

A customer obtained discordant, non-reactive vitros anti-sars-cov-2 total (cov2tot) results from a single patient sample processed using vitros cov2tot lot 0021 on a vitros 5600 integrated system.Patient 1 results of 0.53, 0.58 and 0.80 s/c (non-reactive) versus the expected result of reactive.Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected.The vitros cov2tot results were not reported from the laboratory to a physician and were not used to aid in diagnosis of sars-cov-2 infection.Patient management was not influenced based on the vitros results and ortho is not aware of any allegation of actual patient harm as a result of this event.This report is number one of three mdr¿s for this event.Three 3500a forms are being submitted for this event as a total of three devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho).Complaint numbers (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-SARS-COV-2 TOTAL 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; 100 indigo creek drive; rochester NY 14626
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 10257048
• MDR Text Key: 199238384
• Report Number: 1319681-2020-00042
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• 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: 6199922
• Device Lot Number: 0021
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2020
• 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