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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 DIAGNOSTICS

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ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS CKMB SLIDES IN VITRO DIAGNOSTICS Back to Search Results
Catalog Number 8001133
Device Problem Low Test Results (2458)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/01/2020
Event Type  malfunction  
Manufacturer Narrative
The investigation determined that lower than expected vitros ckmb results were obtained from vitros performance verifier quality control fluids run on a vitros 250 chemistry system. User error due to improper vitros qc fluid and ckmb slide cartridge handling were the likely contributing factors to this event. Qc fluid handling & storage was a contributor to this issue as the customer uses the qc fluids until the bottle is empty instead of following the vitros isoenzyme pv instructions for use that states the qc fluid is stable for 5 days when stored at 2-8c. The vitros ckmb assay is sensitive to slide cartridge storage and handling. The customer stores the vtros ckmb slides frozen, load for a calibration event and then refreeze until the slide lot put into use. In addition, once the slide cartridge is placed on the analyzer it is used until cartridge inventory is depleted, which could go beyond 1 week. Per the vitros ckmb instructions for use, the slide cartridge unopened is to be stored frozen. Once opened it is stable for =
1 week on the analyzer. Therefore, pre-analytical slide cartridge handling is a contributor to the event. An issue with ckmb lot#: 4948-0234-5974 cannot be ruled out as a potential contributor to the event. However, ongoing tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros ckmb lot#: 4948-0234-5974. An instrument related issue cannot be completely ruled out as no diagnostic within-run precision testing was performed to assess the performance of the vitros 250 chemistry system. (b)(6).
 
Event Description
The customer reported lower than expected vitros ckmb results were obtained from vitros performance verifier quality control (qc) fluids run on a vitros 250 chemistry system. Vitros pvi lot f7683
=
9. 3, 9. 0, 9. 6, 10. 0, 10. 4, 9. 2, 9. 6, 8. 9, 10. 2, 9. 5, 9. 7, 10. 3 versus expected 16. 7. 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 than expected results were obtained on quality control fluids. There were no reports of erroneous patient results obtained, or reported from the laboratory. There was no allegation of patient harm as a result of this event. This report corresponds to ortho clinical diagnostics inc. Complaint number: (b)(4).
 
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Brand NameVITROS CHEMISTRY PRODUCTS CKMB 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
1000 lee road
rochester NY 14606
Manufacturer Contact
joseph falvo
100 indigo creek drive
rochester, NY 14626
5854533000
MDR Report Key10929780
MDR Text Key219352261
Report Number1319809-2020-00167
Device Sequence Number1
Product Code JHS
Combination Product (y/n)N
Reporter Country CodeSP
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 12/01/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/01/2021
Device Catalogue Number8001133
Device Lot Number4948-0234-5974
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/03/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/30/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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