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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 02/14/2020
Event Type  malfunction  
Manufacturer Narrative
The investigation concluded that higher than expected ammonia results were obtained from samples from two different patients using vitros chemistry products amon slides lot 1018-0252-2336 on a vitros 5600 integrated system. The investigation was unable to determine a definitive assignable cause for this event. However, a sample related issue related to the affected patients or a transient issue affecting the vitros amon slides in use at the time of the event cannot be ruled out. The issue is isolated only to samples drawn from the affected patients in question, as other patient samples run over this time frame did not demonstrate a similar issue. Historical quality control results exhibited some within-laboratory imprecision, but not to the magnitude observed with the affected samples. In addition, a vitros amon within-run precision test had results within acceptable guidelines indicating vitros amon reagent lot 1018-0252-2336 was performing as intended on the vitros 5600 integrated system. Continual tracking and trending of complaint data does not indicate a potential systemic issue with vitros amon lot 1018-0252-2336.
 
Event Description
A customer reported higher than expected ammonia (amon) results obtained from samples from two different patients processed using vitros chemistry products amon slides on a vitros 5600 integrated system. Patient 1 vitros amon results of 143. 4 and 246. 1 umol/l vs. The expected result of 101. 2 umol/l. Patient 2 vitros amon results of 111. 9 and 216. 6 umol/l vs. The expected result of 54. 9 umol/l. Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected. The higher than expected patient sample results were not reported outside of the laboratory and there was no allegation of patient harm as a result of this event. This report is number 1 of 4 mdr¿s for this event. Four (4) 3500a forms are being submitted for this event as 4 devices were involved. This report corresponds to ortho clinical diagnostics inc. (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 Key9825005
MDR Text Key225254182
Report Number1319809-2020-00032
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 03/12/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/01/2021
Device Catalogue Number1726926
Device Lot Number1018-0252-2336
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/14/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/04/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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