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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS AMON SLIDES IN-VITRO DIAGNOSTICS

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ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS AMON SLIDES IN-VITRO DIAGNOSTICS Back to Search Results
Catalog Number 1726926
Device Problem High Test Results (2457)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/02/2021
Event Type  malfunction  
Manufacturer Narrative
The investigation determined that higher than expected amon results were obtained when a patient sample was tested using vitros amon lot 1018-0255-3934 on a vitros 350 chemistry system. A definitive cause of the higher than expected vitros amon results was not established with the information provided. A vitros amon lot 1018-0255-3934 slide issue cannot be ruled out as a contributor to the event, as no historical qc results were provided to verify the performance of the vitros amon lot 1018-0255-3934 slides. However, qc results on the date of the event were within acceptable guidelines and ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros amon lot 1018-0255-3934. An instrument issue cannot be ruled out as a contributor to the higher than expected results, as no within run diagnostic precision testing was conducted when requested. The customer indicated the patient sample was not hemolyzed, therefore, hemolysis in the patient sample is an unlikely contributor to the higher than expected results. Patient sample mix up cannot be ruled out as a contributor to the event as it could not be determined whether patient sample mix up had occurred for the event. (b)(6).
 
Event Description
The investigation determined that higher than expected ammonia (amon) results were obtained when a patient sample was tested using vitros amon lot 1018-0255-3934 on a vitros 350 chemistry system. Vitros amon results of 101. 1 and 142. 7 umol/l versus the expected result of 62. 8 umol/l biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples. The higher than expected vitros amon results were not reported from the laboratory. Ortho was not made aware of any allegation of patient harm as a result of this event. This report is number two of two mdr¿s for this event. Two 3500a forms are being submitted for this event as two devices were involved. This report corresponds to ortho clinical diagnostics inc (ortho) (b)(4).
 
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Brand NameVITROS CHEMISTRY PRODUCTS AMON SLIDES
Type of DeviceIN-VITRO DIAGNOSTICS
Manufacturer (Section D)
ORTHO-CLINICAL DIAGNOSTICS
100 indigo creek drive
rochester NY 14626
MDR Report Key12253313
MDR Text Key282123377
Report Number1319809-2021-00124
Device Sequence Number1
Product Code JID
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Type of Report Initial
Report Date 07/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/01/2022
Device Catalogue Number1726926
Device Lot Number1018-0255-3934
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/09/2021
Is This a Reprocessed and Reused Single-Use Device? No

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