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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-SARS-COV-2 TOTAL REAGENT PACK; IN-VITRO DIAGNOSTICS
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ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-SARS-COV-2 TOTAL REAGENT PACK; IN-VITRO DIAGNOSTICS Back to Search Results
Catalog Number 6199922
Device Problems False Positive Result (1227); Non Reproducible Results (4029)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/03/2022
Event Type  malfunction  
Event Description
The investigation determined that a discordant, non-reproducible, false reactive vitros anti-sars cov 2 total (cov2tot) result was obtained when a vitros cov2tot level 1 lot 0530 non-reactive qc fluid was processed on a vitros eci immunodiagnostic system.Vitros cov2tot lot 0530 l1 qc fluid result of 2.09 s/c (reactive) versus the expected result of non-reactive.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 cov2tot result was obtained when a non-patient fluid was processed.Ortho has not been made aware of any allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) nonconformance (b)(4).
 
Manufacturer Narrative
The investigation determined that a discordant, non-reproducible, false reactive vitros anti-sars cov 2 total (cov2tot) result was obtained when a vitros cov2tot level 1 lot 0530 non-reactive qc fluid was processed on a vitros eci immunodiagnostic system.A definitive cause of the event was not established.A vitros cov2tot lot 0620 reagent issue is an unlikely contributor to the event, as the remaining results from vitros cov2tot lot 0530 qc fluid testing was acceptable.Additionally, ongoing tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros cov2tot lot 0620.An instrument issue cannot be ruled out as a contributor to the event, as it was not known if the instrument was operating as expected at the time the discordant result was obtained as no performance testing was undertaken.Additionally, the false reactive result was isolated to one instrument and the results on the other vitros eci immunodiagnostic system were all acceptable.An issue with the vitros cov2tot lot 0530 l1 qc fluid is a possible contributor to the event as the vitros cov2tot lot 0530 qc fluid had expired (date of expiry 03 february 2022) prior to the date of the event ((b)(6) 2022).The qc fluid was tested as part of ortho post-expiry stability testing qc fluid mix up is an unlikely contributor to the event, as an expected result was obtained around the same time from the same tray/cup as the false reactive vitros cov2tot result of 2.09 s/c.(b)(4).
 
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Brand Name
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-SARS-COV-2 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
felindre meadows
pencoed
bridgend, wales CF35 5PZ
UK   CF35 5PZ
Manufacturer Contact
laurie o'riordan
1295 southwest 29th avenue
pompano beach, FL 33069
9549709500
MDR Report Key13946994
MDR Text Key297977094
Report Number3007111389-2022-00030
Device Sequence Number1
Product Code QKO
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 03/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date06/10/2022
Device Catalogue Number6199922
Device Lot Number0620
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/04/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/21/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
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