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

Catalog Number 6199922

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/03/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that discordant, higher than expected vitros cov2tot results were obtained from two samples from different patients when tested using vitros cov2tot lot 0016 on a vitros 5600 integrated system.The vitros cov2tot results were discordant when compared to non-vitros (roche and abbott) antibody testing results for the same patients.A definitive assignable cause for the discordant, higher than expected results could not be determined.Based on historical quality control results a vitros cov2tot lot 0016 reagent performance issue is not a likely contributor to the event as all vitros quality control fluid results were within the correct vitros cov2tot instructions for use result 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 0016.There is no indication of any instrument malfunction and unexpected instrument performance is not a likely contributor to the event.However, a suitable precision test was not run by the customer when requested, therefore an instrument issue cannot be completely ruled out as a contributor to the event.In addition, it was not possible to establish if the customer is following the sample collection device manufacturer¿s recommended centrifugation protocol; therefore, pre-analytical sample processing cannot be ruled out as a contributing factor.It is possible that cellular debris, due to poor sample preparation, was present in the affected samples, although this could not be confirmed.

Event Description

An ortho clinical diagnostics (ortho) laboratory specialist (ls) contacted the (b)(6) on behalf of a customer to report discordant, reactive vitros anti- sars-cov-2 total (cov2tot) results obtained from samples from two different patients when tested on a vitros 5600 integrated system.The vitros cov2tot results were discordant when compared to non-vitros (roche and abbott) antibody testing results for the same patients.Patient 1, vitros cov2tot result of 2.08 s/c (reactive) versus the expected result of non-reactive patient 2, vitros cov2tot result of 1.69 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.The vitros cov2tot results were not reported from the laboratory to a physician.There was no allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-SARS-COV-2 TOTAL 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; 100 indigo creek drive; rochester NY 14626
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 10212667
• MDR Text Key: 197773400
• Report Number: 1319681-2020-00040
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2020
• Device Catalogue Number: 6199922
• Device Lot Number: 0016
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2020
• 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