Catalog Number 8433880 |
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 10/25/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation determined that higher and lower than expected vitros lac quality control results were obtained from vitros control fluids using two different lots of vitros lac slides on a vitros 350 chemistry system.A definitive assignable cause could not be determined.There is no evidence that a vitros 350 system occurred.The unacceptable historical vitros lac quality control results obtained from the customer indicate that the vitros lac lot 3530-0092-3271 was not performing as intended.However, it is suspected that the customer is not following correct protocol when reconstituting the calibrator and control fluids but could not be confirmed.
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Event Description
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The customer observed higher and lower than expected vitros lac quality control results from vitros control fluids using two different lots of vitros lac slides on a vitros 350 chemistry system.(b)(6).Biased results of the direction and magnitude observed may lead to inappropriate physician action.Although there were no reports of affected patient sample results, it cannot be confirmed that patient sample results were not affected and would not be affected if the event were to recur undetected.There were no allegations of patient harm.This report is number five of twenty mdr's for this event.Twenty 3500a forms are being submitted for this event as twenty devices were involved.(b)(4).
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Search Alerts/Recalls
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