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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 Test Results (2457)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/03/2021
Event Type  malfunction  
Event Description
The investigation determined that a higher than expected ammonia (amon) result was obtained when the customer processed a non-vitros (mas) qc fluid using vitros amon lot 1018-0256-9804 on a vitros xt7600 integrated system. Mas lot aa22022a level 2 result of 301. 835 umol/l versus the customer¿s estimated baseline mean result of 179 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 the customer was processing a non-patient fluid. Ortho was not made aware of any allegation of patient harm as a result of this event. This report corresponds to ortho clinical diagnostics inc (ortho) complaint (b)(4).
 
Manufacturer Narrative
The investigation determined that a higher than expected ammonia (amon) result was obtained when the customer processed a non-vitros (mas) quality control (qc) fluid using vitros amon lot 1018-0256-9804 on a vitros xt7600 integrated system. A definitive assignable cause of the event was not determined. An instrument issue cannot be ruled out as a contributor to the event as no diagnostic precision testing was conducted around the time of the event ((b)(6) 2021); therefore it cannot be determined whether the instrument was performing as expected when the higher than expected result was obtained. Qc results following ortho field engineer service actions performed on 13 october 2021 were acceptable in terms of amon accuracy and precision. However, since the service was over 5 weeks after the day of the event, it cannot be confirmed or ruled out if an instrument issue contributed to the event. A vitros amon lot 1018-0256-9804 issue cannot be ruled out as a contributor to the event, as historical qc results indicated unacceptable precision leading up to the event on (b)(6) 2021. However, ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros amon lot 1018-0256-9804. (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
laurie o'riordan
1295 southwest 29th avenue
pompano beach, FL 33069
9549709500
MDR Report Key12775238
MDR Text Key285072417
Report Number1319809-2021-00159
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 11/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1726926
Device Lot Number1018-0256-9804
Was Device Available for Evaluation? Yes
Date Manufacturer Received10/12/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/28/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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