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

Catalog Number 6199922

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/27/2020

Event Type  malfunction  

Manufacturer Narrative

A customer communication ((b)(4)) was sent (b)(6) 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

A retrospective review of all e-connected vitros instruments that processed samples from vitros immunodiagnostic products anti-sars-cov2 total reagent pack (vitros cov2 total), lots 10 ¿ 18 and 21 ¿ 37 were reviewed as part of an ortho investigation.It was determined that the two bottles which make up vitros cov2 total lot 17 ((b)(4)), vitros cov2 total lot 27 ((b)(4)), and vitros cov2 total lot 30 ((b)(4)) 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.False negative vitros cov2 total results may 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 as the customer did report this event to ortho.A customer communication ((b)(4)) was sent (b)(6) 2020 to all vitros customers that were shipped the affected vitros cov2-total reagent lots.This report is number 2 of 5 mdr¿s for this event.Five (5) 3500a forms are being submitted for this event as 5 devices were involved.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: 10330039
• MDR Text Key: 201171490
• Report Number: 1319681-2020-00054
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/16/2020
• Device Catalogue Number: 6199922
• Device Lot Number: 17
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2020
• 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