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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK IN VITRO DIAGNOSTIC

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ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK IN VITRO DIAGNOSTIC Back to Search Results
Catalog Number 1896836
Device Problem Low Test Results (2458)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/05/2017
Event Type  malfunction  
Manufacturer Narrative
The investigation has determined that a non-reproducible, lower than expected vitros tropi es result and a vitros ckmb result were obtained from a patient sample using the vitros 5600 integrated system. A definitive root cause could not be determined. Based on acceptable performance of historical tropi es and ckmb quality control data, a reagent issue was ruled out as a potential contributing factor. An instrument related event has been ruled out as a contributing factor as within run precision testing was within the acceptable guidelines. Pre-analytical sample processing could not be ruled out as a contributing factor, as it is unknown if the customer is adhering to the sample collection device manufacturer¿s recommendations for sample centrifugation. It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.
 
Event Description
A customer obtained non-reproducible, lower than expected troponin i and ckmb results from a patient sample using vitros troponin i es (tropi) reagent and vitros ckmb reagent on a vitros 5600 integrated system. Patient sample results: vitros tropi es result <0. 012 ng/ml versus expected vitros tropi es result 1. 88 ng/ml. Vitros ckmb result 0. 25 ng/ml versus expected vitros ckmb result 19. 6 ng/ml. A biased result of the direction and magnitude observed may lead to inappropriate medical action if not detected. The higher than expected results were not reported from the laboratory and there was no allegation patient harm. This report is number two of two mdr's for this event. Two 3500a forms are being submitted for this event as two devices were involved. This report corresponds to ortho clinical diagnostics inc. Complaint number (b)(4).
 
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Brand NameVITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK
Type of DeviceIN VITRO DIAGNOSTIC
Manufacturer (Section D)
ORTHO-CLINICAL DIAGNOSTICS
100 indigo creek drive
rochester NY 14626
Manufacturer (Section G)
ORTHO CLINICAL DIAGNOSTICS
felindre meadows
pencoed
bridgend, wales CF35 5PZ
UK CF35 5PZ
Manufacturer Contact
james a stevens
100 indigo creek drive
rochester, NY 14626
5854533000
MDR Report Key6919005
MDR Text Key89941394
Report Number3007111389-2017-00154
Device Sequence Number1
Product Code JHX
Combination Product (y/n)N
Reporter Country CodeKS
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 10/05/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/05/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/09/2018
Device Catalogue Number1896836
Device Lot Number2150
Other Device ID Number10758750000203
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 Received09/07/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/02/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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