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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 Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/01/2020
Event Type  malfunction  
Manufacturer Narrative
The investigation determined that higher than expected vitros amon results were obtained from vitros performance verifier quality control fluids using vitros amon reagent on a vitros 5600 integrated system. A definitive assignable cause of the event was not established. However, the most likely cause of the event is day to day inconsistencies with quality control fluid handling. Acceptable within run amon and alkp precision test results indicate the vitros 5600 system is performing as expected and is not a contributor of the event or the unacceptable quality control within laboratory precision. The historical vitros amon quality control results indicate unacceptable within laboratory precision. However, acceptable within run amon precision test results verified the system performance; therefore, day to day inconsistencies with fluid handling is the likely cause of the observed imprecision and the higher than expected vitros amon results. In addition, ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros amon slides lot 1018-0253-8819.
 
Event Description
A customer contacted ortho clinical diagnostics (ortho) global technical support center (tsc) to report higher than expected amon (ammonia) results obtained when processing quality control fluids on a vitros 5600 integrated system. Vitros liquid performance verifier i lot k7186. Vitros amon result of 95. 73* umol/l versus the expected vitros amon result of 45. 2 umol/l. Vitros liquid performance verifier ii lot j6667. Vitros amon result of 225. 80* umol/l versus the expected vitros amon result of 186. 9 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 amon results were obtained when processing a quality control fluid. Ortho was not made aware of any allegation of patient harm due to the event. (b)(4). This report is number 1 of 2 mdr¿s for this event. Two (2) 3500a forms are being submitted for this event as 2 devices were involved.
 
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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 Key10236038
MDR Text Key199828603
Report Number1319809-2020-00068
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 07/06/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/06/2020
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 Number1018-0253-8819
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/08/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/28/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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