MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS ANTI-SARS-COV-2 TOTAL REAGENT PACK; IN-VITRO DIAGNOSTICS

Model Number 6199953

Device Problem False Positive Result (1227)

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

Event Date 01/16/2024

Event Type  malfunction  

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report discordant reactive vitros anti- sars-cov-2 total (cv2t) results were obtained from a single vitros reactive quality control fluid processed using vitros cv2t reagent lot 0021 on a vitros xt 7600 integrated system.Vitros reactive control lot 01010 reactive results of 1.030, 1.150, 1.137, 1.15 and 1.14 s/c versus the expected result of 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 discordant, reactive vitros cv2t results were obtained from non-patient quality control samples.There is no allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment (b)(4).

Manufacturer Narrative

The investigation determined that discordant reactive vitros anti- sars-cov-2 total (cv2t) results were obtained from a single vitros reactive quality control fluid processed using vitros cv2t reagent lot 0021 on a vitros xt 76600 integrated system.A definitive assignable cause for the discordant reactive vitros cv2t results could not be determined.Contamination of the affected samples of vitros cv2t negative control that was introduced by the customer cannot be confirmed or ruled out as contributing to the event.An instrument related issue did not likely contribute to the event as a diagnostic vitros tropi es within-in run precision test was acceptable, indicating there was not an issue with high signal background with the instrument.However, a diagnostic vitros tsh within-run precision test, which is used to assess the microwell subsystem of the vitros instrument was not performed as requested.Therefore, an instrument related performance issue cannot be completely ruled out as contributing to the event.A review of the vitros cv2t results in e-connectivity determined a single vitros cv2t reagent lot 0021 reagent pack, pack id 122, was the only reagent pack in use during the timeframe of the event.Expected and unexpected results were obtained from pack id 122, therefore, a performance issue with the reagent pack did not likely contribute to the event.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros cv2t lot 0021.

• Brand Name: ANTI-SARS-COV-2 TOTAL REAGENT PACK
• Type of Device: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; felindre meadows; pencoed; bridgend NY CF35 5PZ; UK CF35 5PZ
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS; felindre meadows; pencoed; bridgend CF35 5PZ; UK CF35 5PZ
• Manufacturer Contact: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 18669676
• MDR Text Key: 336215678
• Report Number: 3007111389-2024-00024
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6199953
• Device Catalogue Number: 6199953
• Device Lot Number: 0021
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1