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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 Consequences Or Impact To Patient (2199)
Event Date 07/05/2019
Event Type  malfunction  
Manufacturer Narrative
The investigation determined that higher and lower than expected vitros amon results were obtained when processing royal college of pathologists of australasia (rcpaqap) proficiency fluids using vitros chemistry products ammonia (amon) slides on a vitros 5,1 fs chemistry system. The definitive assignable cause could not be determined. A precision test was not processed and therefore, an analyzer related issue caused by microslide incubator contamination cannot be ruled out as a potential cause. Historical quality control (qc) results are acceptable for one set of qc provided, but are unacceptable for the level ii fluid for the other two sets of qc provided. It is unknown which reagent lot number was run with each set of qc. An issue with vitros amon lots 1018-0250-3870, 1018-0250-1827, 1018-0250-1816, 1018-0250-1814 and 1018-0249-0347 could not be confirmed or ruled out as a contributor of the event. However, ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros amon reagent lots 1018-0250-3870, 1018-0250-1827, 1018-0250-1816, 1018-0250-1814 or 1018-0249-0347. It is unknown when any of the vitros amon lots listed in the complaint description were put into use, or what lot of vitros amon the customer processed the proficiency samples on. Therefore, a device count of 5 for the 5 slide lots in use will be reported.
 
Event Description
A customer reported imprecise vitros amon results obtained from proficiency fluids using vitros chemistry products ammonia (amon) slides in combination with a vitros 5,1 fs chemistry system. Rcpaqap proficiency fluid 39-01 result of 204 mol/l versus vitros peer mean result of 267 mol/l. Rcpaqap proficiency fluid 39-03 result of 88 mol/l versus vitros peer mean result of 119 mol/l. Rcpaqap proficiency fluid 39-04 result of 132 mol/l versus vitros peer mean result of 169 mol/l. Rcpaqap proficiency fluid 39-07 result of 92 mol/l versus vitros peer mean result of 118 mol/l. Rcpaqap proficiency fluid 39-09 result of 45 mol/l versus vitros peer mean result of 265 mol/l. Rcpaqap proficiency fluid 39-10 result of 223 mol/l versus vitros peer mean result of 69 mol/l. Rcpaqap proficiency fluid 40-04 result of 85 mol/l versus vitros peer mean result of 118 mol/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 lower and higher than expected vitros amon results were obtained when processing unknown external proficiency fluids. However, the investigation cannot conclude that patient sample results were not affected or would not be affected if the event were to recur undetected. Ortho was not made aware of any allegation of patient harm as a result of this event. This report is number 1 of 5 mdr¿s for this event. Five (5) 3500a forms are being submitted for this event as 5 devices were involved. This report corresponds to ortho clinical diagnostics inc. Complaint numbers (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 Key9188358
MDR Text Key214613652
Report Number1319809-2019-00096
Device Sequence Number1
Product Code JID
Combination Product (y/n)N
Reporter Country CodeIS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial
Report Date 10/14/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/14/2019
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 Number1018-0250-3870
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/18/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/11/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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