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

Catalog Number 6199922

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 04/27/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that false non-reactive vitros cov2tot results were obtained when in-house quality control (qc) fluids were tested using vitros cov2tot lot 0310 on a vitros eci immunodiagnostic system.A definitive cause of the false non-reactive vitros cov2tot results was not established.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros cov2tot lot 0310.Qc fluid mix up is a possible contributor to the event, as the false non-reactive vitros cov2tot results of 0.02 s/c were concordant with another in-house qc fluid, s-c1, which yielded eight results of 0.02 s/c upon vitros cov2tot testing.However, qc fluid mix up could not be confirmed by the ortho qe team.Additionally, pre-analytical in-house qc fluid handling is also a possible contributor to the event.An ortho qe indicated that a sample handling error was suspect, however, no further information was provided that could definitively attribute pre-analytical in-house qc fluid handling as the root cause of the event.Quality control fluid results on the day of testing indicate a vitros cov2tot lot 0310 performance issue is not a likely contributor to the event.An instrument issue is also an unlikely contributor to the event, as there was no evidence to suggest an instrument malfunction.However, diagnostic precision testing on the vitros eci immunodiagnostic system was not performed and therefore, an instrument issue cannot be completely ruled out.(b)(6).

Event Description

An ortho quality engineer obtained false non-reactive vitros anti-sars-cov2 total (cov2tot) results when in-house quality control (qc) fluids were tested using vitros cov2tot lot 0310 on a vitros eci immunodiagnostic system.In-house qc fluid c-b6, result of 0.02 s/c (non-reactive) versus the expected result of reactive.In-house qc fluid c-c6, result of 0.02 s/c (non-reactive) versus the expected result of reactive.The non-reactive vitros cov2tot results were obtained when non-patient fluids were being processed as part of in-house testing.However, the investigation could not rule out patient results would not be affected if the event were to recur undetected.There was no reported allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-SARS-COV2 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; felindre meadows; pencoed; bridgend, wales CF35 5PZ; UK CF35 5PZ
• Manufacturer Contact: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 11876166
• MDR Text Key: 252380181
• Report Number: 3007111389-2021-00069
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2021
• Device Catalogue Number: 6199922
• Device Lot Number: 0310
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/27/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/26/2021
• 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