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

Catalog Number 6199922

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

Patient Problem Test Result (2695)

Event Date 09/22/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The investigation determined that discordant reactive vitros anti- sars-cov-2 total (cov2tot) results were obtained from a vitros cov2tot level 1 non-reactive quality control fluid when processed using vitros cov2tot reagent lot 0025 on a vitros 5600 integrated system.The assignable cause of the event was not determined.A review of historical quality control results for vitros cov2tot lot 0025 indicates acceptable performance up to the day of the event.Ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros cov2tot reagent lots 0025.Therefore, a cov2tot lot 0025 reagent issue is not a likely contributor to the event.There was no within run precision testing performed to confirm performance of the vitros 5600 integrated system.An ortho field engineer went on site and performed service actions to multiple analyzer subsystems.Acceptable cov2tot quality control (qc) results were obtained post service suggesting an instrument issue contributed to the event.However, further discordant reactive cov2tot qc results were obtained after service which leads to the conclusion that an instrument issue is not the sole contributing factor.There was no documentation regarding handling and storage of the cov2tot reagent packs and the quality control fluids and pre-analytical sample handling cannot be ruled out as a potential contributing factor.The vitros discordant cov2tot results were not reported from the laboratory to a physician as these are quality control fluids.However, the investigation cannot definitely conclude that patient results would not be affected if the event were to recur undetected.There were no allegations of patient harm as a result of this event.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solutions centre (tsc) to report discordant reactive vitros anti- sars-cov-2 total (cov2tot) results obtained from a quality control fluid processed on a vitros 5600 integrated system.The vitros cov2tot results were considered discordant as the quality control fluid being processed was a non-reactive cov2tot control.Vitros cov2tot level 1 = 8.48, 8.59, 1.34, 1.43, 3.30 s/c (reactive) versus expected non-reactive/negative.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The vitros discordant cov2tot results were not reported from the laboratory as these are quality control fluids.There was no allegation of patient harm as a result of this event.This report is number 1 of 4 mdr¿s for this event.Four (4) 3500a forms are being submitted for this event as 4 devices were involved.This report corresponds to ortho clinical diagnostics inc.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; 100 indigo creek drive; rochester NY 14626
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 10703435
• MDR Text Key: 213722498
• Report Number: 1319681-2020-00099
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2020
• Device Catalogue Number: 6199922
• Device Lot Number: 0025
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2020
• 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