Catalog Number 1912997 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/01/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation has determined that lower than expected vitros tsh results were obtained from a vitros total thyroid (ttc) level 1 control fluid lot 678, when compared to the vitros pi mean, using a vitros tsh reagent on a vitros 3600 immunodiagnostic system.The assignable cause of the lower than expected vitros tsh results using the vitros ttc qc fluid lot 678 could not be determined.Based on historical quality control results, a vitros tsh lot 5375 performance issue is not a likely contributor to the event.Additionally, there was no evidence to suggest a vitros 3600 immunodiagnostic system malfunction and unexpected instrument performance is not a likely contributor to the event.
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Event Description
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A customer obtained lower than expected tsh results when testing vitros total thyroid level 1 control in combination with a vitros 3600 immunodiagnostic system.The following results breached vitros tsh potential health and safety criteria: vitros total thyroid control level 1 lot 0678 tsh results 0.045, 0.051, 0.041,and 0.040 miu/l versus expected tsh result 0.097 miu/l biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The lower than expected vitros tsh qc fluid results were from non-patient fluids and so were not reported from the laboratory.However, the investigation could not conclude patient samples were not affected or would not be affected if the event were to recur undetected.There is no allegation of patient harm as a result of the event.This report is number three of three mdr's for this event.Three 3500a forms are being submitted for this event as three devices were involved.(b)(4).
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Search Alerts/Recalls
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