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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 Problems High Test Results (2457); Low Test Results (2458)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/29/2021
Event Type  malfunction  
Event Description
The investigation determined that lower and higher than expected vitros ammonia (amon) results were obtained from a vitros liquid performance verifier (lpv) control fluid processed using vitros chemistry products amon slides lot 1018-0254-3413 and lot 1018-0255-4014 on a vitros 250 chemistry system. Vitros amon lot 1018-0254-3413: vitros lpv ii lot q8086 results of 148. 0 and 153. 0 umol/l vs an expected result of 193. 7 umol/l vitros amon lot 1018-0255-4014: vitros lpv ii lot q8086 results of 152. 0 and 247. 0 umol/l vs an expected result of 193. 7 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 lower and higher than expected vitros amon results were obtained when processing a control fluid. No results were reported out of the laboratory. There was no reported allegation of patient harm as a result of this event. This report is number four of four mdr¿s for this event. Four 3500a forms are being submitted for this event as four devices were involved. This report corresponds to ortho clinical diagnostics inc (ortho) complaint (b)(4).
 
Manufacturer Narrative
The investigation determined that lower and higher than expected vitros amon results were obtained from a vitros liquid performance verifier control fluid processed using vitros chemistry products amon slides lot 1018-0254-3413 and lot 1018-0255-4014 on a vitros 250 chemistry system. A definitive assignable cause could not be determined based on the information provided. Based on historical quality control results, a vitros amon reagent issue cannot be ruled out as a potential contributing factor of the event. However, continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros amon reagent lot 1018-0254-3413 or 1018-0255-4014. An instrument related issue cannot be ruled out as contributor of the event as historical qc results were imprecise using both vitros amon reagent lots. Additionally, no precision testing was performed on the vitros 250 system to verify instrument performance. The customer elected not to troubleshoot the issue further as they will be converting from a vitros 250 chemistry system to a vitros 4600 chemistry system. The customer decided to suspend vitros amon processing until the vitros 4600 system has been implemented. (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 Key12668497
MDR Text Key284287373
Report Number1319809-2021-00155
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 10/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/20/2021
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 Number1018-0255-4014
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/22/2021
Is This a Reprocessed and Reused Single-Use Device? No

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