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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 High Test Results (2457)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/05/2021
Event Type  malfunction  
Manufacturer Narrative
The investigation determined that repeatable elevated vitros ckmb results were obtained from two samples collected from the same patient using vitros ckmb slides on a vitros 5600 integrated system. The elevated vitros ckmb results are most likely due to the presence of a macro ck type i or type ii interferent as described in the vitros ckmb ifu. The customer sent one of the patient samples for testing on an alternate vidas biomerieux method, which produced a result in the negative range. The customer also did not test a second sample within the 18 hour recommendation listed in the ifu, however there was no significant fall in activity in the second sample collected approximately two and a half weeks after the initial sample, indicating that the elevated ckmb is most likely due to the presence of macro ck type i or type ii as described in the ifu. Historical quality control results for vitros ckmb are within expectation, indicating that an issue with the vitros ckmb slides is not likely. Additionally, a vitros alkp diagnostic precision was within ortho acceptable guidelines, indicating that the vitros 5600 integrated system was performing as expected. Although the precision was not run at the time that the initial results were produced, it was run on the same day that the samples were repeated and gave similar results to the original, indicating that the instrument performance had not likely changed between the time of the initial and repeat runs. (b)(4).
 
Event Description
The investigation determined that repeatable elevated vitros ckmb results were obtained from two samples collected from the same patient using vitros ckmb slides on a vitros 5600 integrated system. Vitros ckmb patient results of 266, 267, 267, 210, and 225 (positive) versus the expected result of negative. Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples. The elevated vitros ckmb results were not reported by the laboratory. There was no allegation of patient harm as a result of this event. This report is number one 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 (ortho) 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
MDR Report Key12135463
MDR Text Key281432557
Report Number1319809-2021-00114
Device Sequence Number1
Product Code JHS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Type of Report Initial
Report Date 07/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/01/2021
Device Catalogue Number8001133
Device Lot Number4947-0233-9102
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/10/2021
Is This a Reprocessed and Reused Single-Use Device? No

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