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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS CKMB SLIDES IN-VITRO DIAGNOSTIC

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ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS CKMB SLIDES IN-VITRO DIAGNOSTIC Back to Search Results
Catalog Number 8001133
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/21/2016
Event Type  malfunction  
Manufacturer Narrative
The assignable cause of the event is a known limitation of the vitros ckmb slide assay. The results of the non-vitros fractionation indicate that 34% of the total ck enzyme in the sample consists of the macro type i isoenzyme. Per the vitros ckmb slide assay instruction for use (ifu), macro ck type i and type ii can cause falsely elevated vitros ckmb results. There was no indication the vitros ckmb microslide reagent or the vitros 5600 instrument malfunctioned.
 
Event Description
The customer reported higher than expected vitros ckmb results were obtained from a single patient sample using two different lots of vitros ckmb slides on a vitros 5600 analyzer, when compared to a non-vitros fractionation method. Biased results of the direction and magnitude observed may lead to inappropriate physician action. Vitros ckmb slide lot 4935-0202-5258. Patient sample result of 104 u/l vs. The expected result of <16 u/l. Vitros ckmb slide lot 4935-0202-6522. Patient sample result of 104 u/l vs. The expected result of <16 u/l. The higher than expected results were not reported outside of the laboratory. There was no report of patient harm as a result of this event. 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. (b)(4).
 
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Brand NameVITROS CHEMISTRY PRODUCTS CKMB SLIDES
Type of DeviceIN-VITRO DIAGNOSTIC
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 Key5484888
MDR Text Key40032544
Report Number1319809-2016-00032
Device Sequence Number1
Product Code JHS
Combination Product (y/n)N
Reporter Country CodeIT
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 03/07/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/07/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/01/2017
Device Catalogue Number8001133
Device Lot Number4935-0202-5258
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/12/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/11/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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