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 Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/20/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined the likely cause of the (b)(4) (alu is too small) condition codes is an issue associated with the vitros cov2 total reagent pack.It was determined, via econnectivity, that the two bottles which make up vitros cov2 total (pack id (b)(4)) were interchanged (swapped) 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.There was a total of 37 patient results obtained from vitros cov2 total pack id (b)(4).Of the 37 samples, 5 were associated with (b)(4) and the results for those 5 samples were suppressed.It is unknown if the any patient result(s) were affected or reported to a clinician.Since the customer did not report the result directly to ortho clinical diagnostics, it is assumed there were no allegations of patient harm.However, it cannot be concluded that patient sample results would not be affected if the event were to recur undetected.This issue is associated with investigation (b)(4) (anti sars cov 2 total and anti sars cov 2 igg reagent pack bottles switched).Ortho is in the process of issuing a customer letter to those who were shipped vitros cov2 total reagent lots which were manufactured using a manual process to insert the bottles onto the frame of the reagent pack.

Event Description

A customer obtained (b)(4) (alu is too small) for multiple samples when using vitros immunodiagnostics products anti- sars-cov-2 total, lot 0017 on a vitros xt 7600 system.The occurrence of (b)(4) codes may be indicative of several scenarios that meet the criteria for being classified as a potential health and safety complaint.Ortho was not made aware of any allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho).Complaint number (b)(4).

Manufacturer Narrative

This supplemental emdr 472708 is being created to update the initial emdr 472468 to include information associated with a recall issued on 17 july 2020 and customer communication (cl2020-191) sent 17 july 2020.The fda was notified of this issue on wednesday 15 july 2020.Refer to report number 1319681-07/15/2020-001-c.A customer communication (cl2020-191) 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.

Event Description

This report corresponds to ortho clinical diagnostics inc (ortho).Complaint number (b)(4) and (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
• MDR Report Key: 10293553
• MDR Text Key: 200589983
• Report Number: 1319681-2020-00049
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/16/2020
• Device Catalogue Number: 6199922
• Device Lot Number: 0017
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/20/2020
• Initial Date FDA Received: 07/19/2020
• Supplement Dates Manufacturer Received: 06/20/2020
• Supplement Dates FDA Received: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1