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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 DIAGNOSTIC

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ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS AMON SLIDES IN-VITRO DIAGNOSTIC Back to Search Results
Catalog Number 1726926
Device Problem High Readings (2459)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/29/2021
Event Type  malfunction  
Manufacturer Narrative
The investigation determined that a higher than expected amon (ammonia) result was obtained from a non-vitros (mas) quality control (qc) fluid when tested using vitros amon lot 1018-0254-2654 on a vitros 5600 integrated system. A definitive assignable cause could not be determined at the time of this report. However, the most likely assignable cause of the event is an instrument related issue. Precision testing and historical qc results were imprecise and were not within acceptable guidelines. After service actions were performed by an ortho field engineer (fe) which included decontaminating the cm/rt ring, replacing the microslide metering pump, and replacing a humidity cartridge to repair a humidity cover plate air leak, post-service vitros amon precision testing was conducted which yielded results that were not within ortho acceptable guidelines. Prior to service, the customer had reported that the evaporation caps were dirty. It is unknown if the customer cleaned or replaced the evaporation caps. The most likely cause of the event is an instrument related issue, however, because service did not resolve the issue, an instrument related issue cannot be confirmed. At the time of this report, another visit to the site for the fe was scheduled by the tsc along with recommendations to complete the full microslide incubator ammonia decontamination procedure on the vitros 5600 system. In addition, an issue related to the use of ammonia based cleaning products could not be entirely confirmed nor ruled out as a possible contributor of the event as the customer confirmed that no such products had been used on the vitros 5600 system, however, could not confirm whether such products had been used in the laboratory around the instrument. A vitros amon reagent lot 1018-0254-2654 related issue is not a likely contributor of the event as unexpected results had also been obtained on the vitros 5600 integrated system using an alternate lot of vitros amon reagent. However, as a definitive cause was not established, a reagent related issue could not be entirely ruled out. 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 1018-0254-2654. Email address for contact office is (b)(4).
 
Event Description
A customer obtained a higher than expected amon (ammonia) result from a non-vitros (mas) quality control (qc) fluid when tested using vitros amon lot 1018-0254-2654 on a vitros 5600 integrated system. Mas lot aa22022a, vitros amon result of 237. 6 umol/l vs the expected result of 164. 0 umol/l. Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected. The higher than expected vitros amon result was obtained when processing a control fluid. No results were reported out of the laboratory. However, the investigation cannot conclude that patient sample results were not affected or would not be affected if the event were to recur undetected. There was no reported allegation of actual patient harm as a result of this event. This report corresponds to ortho clinical diagnostics inc (ortho). Complaint numbers (b)(4).
 
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Brand NameVITROS CHEMISTRY PRODUCTS AMON SLIDES
Type of DeviceIN-VITRO DIAGNOSTIC
Manufacturer (Section D)
ORTHO-CLINICAL DIAGNOSTICS
100 indigo creek drive
rochester NY 14626
Manufacturer (Section G)
ORTHO-CLINICAL DIAGNOSTICS
513 technology blvd.
rochester NY 14652
Manufacturer Contact
laurie o'riordan
100 indigo creek drive
rochester, NY 14626
5854533000
MDR Report Key11373435
MDR Text Key262927534
Report Number1319809-2021-00014
Device Sequence Number1
Product Code JID
Combination Product (y/n)N
Reporter Country CodeBE
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial
Report Date 02/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/01/2022
Device Catalogue Number1726926
Device Lot Number1018-0254-2654
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/01/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/14/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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