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U.S. Department of Health and Human Services

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

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ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS CKMB REAGENT PACK IN VITRO DIAGNOSTICS Back to Search Results
Catalog Number 1896836
Device Problem High Test Results (2457)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/24/2020
Event Type  malfunction  
Manufacturer Narrative
The investigation determined that higher than expected vitros ckmb results were obtained from cliniqa quality control lot#: 2005075 processed on a vitros 5600 integrated system. The assignable cause of the event was not determined as inventory of ckmb lot 2821 was depleted. A review of historical cliniqa qc data with vitros ckmb lot 2821 indicated precision issues on all levels of control. A within run precision test was processed using cliniqa controls and acceptable precision and accuracy results were obtained indicating the vitros ckmb lot 2821 in combination with the vitros 5600 system was performing as expected at the time of precision testing. This would suggest a potential issue with day to day storage and handling of qc fluids but this was not confirmed. Therefore, pre-analytical qc fluid handling and storage could not be ruled out as a potential contributing factor to this event. A complaint review found no additional complaints for qc high or precision issues using this ckmb lot. In addition, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with this vitros ckmb lot#: 2821. Email address for contact office above is (b)(6).
 
Event Description
The customer reported that higher than expected vitros ckmb results were obtained from cliniqa quality control lot #: 2005075 processed on a vitros 5600 integrated system. Cliniqa level 1
=
4. 82, 4. 85, 4. 86, 4. 81, 4. 71 versus expected 3. 03 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 customer did not process ckmb testing on patient samples since qc was unacceptable. However, the investigation cannot conclude that patient sample test results would not be affected if the event were to recur undetected. There was no allegation of patient harm. This report corresponds to ortho clinical diagnostics inc. Complaint number: (b)(4).
 
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Brand NameVITROS IMMUNODIAGNOSTIC PRODUCTS CKMB 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
joseph falvo
100 indigo creek drive
rochester, NY 14626
5854533000
MDR Report Key11002410
MDR Text Key222023725
Report Number3007111389-2020-00203
Device Sequence Number1
Product Code JHX
Combination Product (y/n)N
Reporter Country CodeRQ
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 12/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/06/2021
Device Catalogue Number1896836
Device Lot Number2821
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/24/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/09/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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