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

Catalog Number 6199922

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 10/05/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that the reagent and conjugate bottles were switched within the vitros cov2tot lot 0027 reagent pack.This issue is associated with investigation fi 471026 (anti sars cov 2 total and anti sars cov 2 igg reagent pack bottles switched).A customer communication ((b)(4)) was sent 17 july 2020 to all customers who were shipped affected lots of vitros anti-sars-cov-2 total and vitros anti-sars-cov-2 igg reagent.The letter indicates if the two reagent bottles are interchanged (swapped), the correct reaction scheme does not occur.This can result in false negative results for a sample that is reactive, calibration failures and quality control failures for the reactive control.The letter instructs customers to visually inspect the reagent pack prior to loading to ensure correct reagent bottle configuration.The fda was notified of this issue on wednesday 15 july 2020.Refer to report number (b)(4).

Event Description

The customer reported that 541-014 condition codes were posted on the vitros eci immunodiagnostic system.It was determined that a reagent pack was used to process samples in which the two bottles that make up vitros cov2 total lot 11 (pack id 0005) were interchanged during the manufacture process.Therefore, the correct reagents were not added in the correct quantities at the correct time during the processing of the assay and the correct reaction scheme likely did not occur.This can lead to false negative results.Although no results were generated it is possible that false negative vitros cov2 total results may be generated and could lead to inappropriate physician action if they were to occur undetected on patient samples.It is unknown if any erroneous vitros cov2 total results were reported to a physician prior to the customer reporting this event to ortho.A customer communication ((b)(4)) was sent 17 july 2020 to all vitros customers that were shipped the affected vitros cov2-total reagent lots.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; 100 indigo creek drive; rochester NY 14626
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 10750739
• MDR Text Key: 214830260
• Report Number: 1319681-2020-00112
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: RQ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/04/2020
• Device Catalogue Number: 6199922
• Device Lot Number: 027
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2020
• 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