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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS SARS-COV-2 ANTIGEN REAGENT IN-VITRO DIAGNOSTIC

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ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS SARS-COV-2 ANTIGEN REAGENT IN-VITRO DIAGNOSTIC Back to Search Results
Catalog Number 6199949
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem Test Result (2695)
Event Date 12/13/2020
Event Type  malfunction  
Manufacturer Narrative
The investigation determined that discordant non-reactive and discordant reactive vitros sars cov 2 antigen (cv2ag) results were obtained from samples from multiple different patients when tested using vitros cv2ag lot 0014 on two different vitros 5600 integrated systems a definitive cause of the discordant false non-reactive and the discordant false reactive vitros cv2ag results was not determined. Discordant vitros cv2ag results were obtained on (b)(6) 2020 and (b)(6) 2021, therefore it is possible that potential causes of the events varied between each date. An issue with the customer¿s vitros 5600 integrated systems cannot be ruled out as a contributor to the event, as the results for patients 2, 3, 5 and 11 were discordant when compared to vitros cv2ag from the customer¿s other vitros 5600 integrated system. An ortho fe was due to visit the customer site to verify the performance of the instruments on (b)(6) 2021. No information was provided regarding the handling of the nasopharyngeal patient samples, therefore a patient sample handling issue cannot be ruled out as a contributor to the event. A vitros cv2ag lot 0014 reagent issue is an unlikely contributor to the event, as qc results around the time of the discordant vitros cv2ag results were acceptable. Additionally, ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros cv2ag lot 0014. A definitive assignable cause for the event could not be determined. (b)(4).
 
Event Description
A customer reported both discordant non-reactive and reactive vitros sars cov 2 antigen (cv2ag) results obtained from samples from multiple different patients when tested using vitros cv2ag lot 0014 on two different vitros 5600 integrated systems. The results were discordant compared to pcr results from the same patient samples. Additionally, vitros cv2ag results were also discordant against alternative vitros cv2ag results for the same patients in some cases. False non-reactive vitros cv2ag results: patient 3, vitros cv2ag result of 0. 97 s/c (non-reactive) versus a vitros cv2ag result of 1. 01 s/c (reactive) and a positive pcr result. Patient 6, vitros cv2ag results of 0. 90, 0. 34 s/c (non-reactive) versus a positive pcr result. Patient 7, vitros cv2ag results of 0. 87, 0. 41 s/c (non-reactive) versus a positive pcr result. Patient 8, vitros cv2ag results of 0. 69, 0. 61 s/c (non-reactive) versus a positive pcr result. Patient 9, vitros cv2ag results of 0. 59, 0. 40 s/c (non-reactive) versus a positive pcr result. Patient 11, vitros cv2ag result of 0. 73 s/c (non-reactive) versus a vitros cv2ag result of 1. 23 s/c (reactive) and a positive pcr result. False reactive vitros cv2ag results: patient 2, vitros cv2ag result of 1. 08 s/c (reactive) versus a negative pcr result. Patient 5, vitros cv2ag result of 1. 42 s/c (reactive) versus a negative pcr result. Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected. The vitros cv2ag results were not reported from the laboratory to a physician and patient management was not influenced based on the vitros results as the vitros cv2ag reagent assay was under validation at the customer site. There was no allegation of actual patient harm as a result of this event. This report is number three of three mdr¿s for this event. Three 3500a forms are being submitted for this event as three devices were involved. This report corresponds to ortho clinical diagnostics inc (ortho). Complaint numbers (b)(4).
 
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Brand NameVITROS IMMUNODIAGNOSTIC PRODUCTS SARS-COV-2 ANTIGEN REAGENT
Type of DeviceIN-VITRO DIAGNOSTIC
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
joseph falvo
100 indigo creek drive
rochester, NY 14626
5854533000
MDR Report Key11169267
MDR Text Key228020795
Report Number1319681-2021-00003
Device Sequence Number1
Product Code QKP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 03/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/09/2021
Device Catalogue Number6199949
Device Lot Number0014
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/17/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/20/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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