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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 DIAGNOSTICS

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ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK IN-VITRO DIAGNOSTICS Back to Search Results
Catalog Number 1896836
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/09/2021
Event Type  malfunction  
Manufacturer Narrative
The investigation has determined that higher than expected vitros ck-mb results were obtained from three different samples drawn from a single patient using vitros immunodiagnostics product ck-mb reagent pack on a vitros 5600 integrated system. The assignable cause for the higher than expected vitros ck-mb results for the patient is the presence of a heterophilic sample interferent present in the three patient samples tested. Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros ck-mb reagent lot 2910. Email address for contact office is (b)(4).
 
Event Description
The investigation has determined that higher than expected vitros ck-mb results were obtained from three different samples collected from a single patient using vitros immunodiagnostics product ck-mb reagent lot 2910 on a vitros 5600 integrated system. The three samples were collected over three consecutive dates. Patient results
=
14. 6, 14. 5, 14. 5, 14. 2 and 14. 5 ng/ml versus the expected result of 1. 7 ng/ml. 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 ck-mb results were reported from the laboratory. Based on the reported vitros ck-mb results a medical procedure was delayed, however, no other details regarding the medical procedure were given upon request. Ortho has not been made aware of any allegation of patient harm as a result of this event. This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4).
 
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Brand NameVITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK
Type of DeviceIN-VITRO DIAGNOSTICS
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
laurie o'riordan
1295 southwest 29th avenue
pompano beach, FL 33069
9549709500
MDR Report Key11734591
MDR Text Key265023186
Report Number3007111389-2021-00062
Device Sequence Number1
Product Code JHX
Combination Product (y/n)N
Reporter Country CodeCH
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 04/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2021
Device Catalogue Number1896836
Device Lot Number2910
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/15/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/02/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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