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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 High Readings (2459)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/25/2018
Event Type  malfunction  
Manufacturer Narrative
The investigation concluded that a higher than expected vitros chemistry products ammonia (amon) result was obtained from an american proficiency institute (api) sample using vitros amon slides on a vitros 350 chemistry system. The customer was unable to provide the exact date the api samples were tested, the vitros amon slide lot in use when the api samples were tested, or any historic quality control results that were generated during the timeframe that the api samples were processed in (b)(6) 2018. Therefore, the cause of the higher than expected vitros amon result obtained from api sample am-06 cannot be determined. An instrument, reagent, or sample handling issue cannot be ruled out as possible causes of the event.
 
Event Description
A customer reported a higher than expected result obtained from an american proficiency institute (api) sample using vitros chemistry products amon slides on a vitros 350 chemistry system. Api am-06 proficiency sample vitros amon result of 270 umol/l vs. The expected result of 218. 8 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 vitros amon result was obtained when processing api fluids. There was no report of affected patient results, 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 were no allegations 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 Key8711461
MDR Text Key212154901
Report Number1319809-2019-00043
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 06/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/01/2020
Device Catalogue Number1726926
Device Lot Number1018-0250-3889
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/24/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/14/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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