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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 Low Readings (2460)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/04/2020
Event Type  malfunction  
Manufacturer Narrative
The investigation determined that a lower than expected vitros amon result was obtained from a vitros liquid performance verifier (lpv) quality control fluid using vitros amon reagent on a vitros 5600 integrated system. A definitive assignable cause of the event was not established. A within run vitros amon precision was not processed, and it is unknown if any additional troubleshooting was performed aside from calibrating the vitros amon. Therefore, an analyzer issue cannot be confirmed or ruled out as a possible cause of the lower than expected vitros amon result. A vitros pv fluid issue is an unlikely contributor to the event, as acceptable pv results from both lpv i lot p8085 and lpv ii lot q8086 were obtained following the event. Fluid handling protocol was not provided therefore a quality control fluid handling issue cannot be ruled out as a contributor to the event. Quality control results showed unacceptable laboratory precision leading up to the day of the event but have been acceptable since the event. It is possible that day to day inconsistencies with lpv fluid handling is the cause of the unacceptable within laboratory precision, although this cannot be confirmed. Continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros amon slides lot 1018-0253-7843.
 
Event Description
A customer contacted the ortho clinical diagnostics (ortho) global technical support center (tsc) to report lower than expected vitros amon (ammonia) results obtained when processing quality control fluids on a vitros 5600 integrated system. Vitros lpv ii lot q8086 result of 149. 58 umol/l versus the 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. There was no reported allegation of patient harm as a result of this event. This report corresponds to ortho clinical diagnostics inc. Complaint number (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
Manufacturer (Section G)
ORTHO-CLINICAL DIAGNOSTICS
513 technology blvd.
rochester NY 14652
Manufacturer Contact
james a stevens
100 indigo creek drive
rochester, NY 14626
5854533000
MDR Report Key10602684
MDR Text Key231138582
Report Number1319809-2020-00112
Device Sequence Number1
Product Code JID
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
Type of Report Initial
Report Date 09/29/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/01/2021
Device Catalogue Number1726926
Device Lot Number1018-0253-7843
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/04/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/05/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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