Catalog Number 8001133 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/21/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The assignable cause of the event is a known limitation of the vitros ckmb slide assay.The results of the non-vitros fractionation indicate that 34% of the total ck enzyme in the sample consists of the macro type i isoenzyme.Per the vitros ckmb slide assay instruction for use (ifu), macro ck type i and type ii can cause falsely elevated vitros ckmb results.There was no indication the vitros ckmb microslide reagent or the vitros 5600 instrument malfunctioned.
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Event Description
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The customer reported higher than expected vitros ckmb results were obtained from a single patient sample using two different lots of vitros ckmb slides on a vitros 5600 analyzer, when compared to a non-vitros fractionation method.Biased results of the direction and magnitude observed may lead to inappropriate physician action.Vitros ckmb slide lot 4935-0202-5258.Patient sample result of 104 u/l vs.The expected result of <16 u/l.Vitros ckmb slide lot 4935-0202-6522.Patient sample result of 104 u/l vs.The expected result of <16 u/l.The higher than expected results were not reported outside of the laboratory.There was no report of patient harm as a result of this event.This report is number 1 of 2 mdr's for this event.Two (2) 3500a forms are being submitted for this event as 2 devices were involved.(b)(4).
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Search Alerts/Recalls
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