Catalog Number 6801042 |
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 07/25/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation confirmed that lower than expected myoglobin results were obtained from a non-vitros quality control fluid using vitros immunodiagnostics products myoglobin reagent pack lot 1220 on a vitros 5600 integrated system (b)(4).The assignable cause is attributed to user error associated with an unknown maintenance issue as the qc shift low occurred after the customer performed maintenance actions on the vitros 5600 integrated system.The same biorad qc fluid was run on the customers alternative analyzer without experiencing the same shift.A review of the historical qc results for vitros myoglobin indicates performance was acceptable prior to and up to the date of the maintenance, and therefore vitros myoglobin lot 1220 performance issue is not a likely contributor to the event.The customer repeated the maintenance actions of cleaning the microwell incubator, the signal reagent probe, the well wash probe, and replacing the vapor adsorption cartridge and subsequent qc results were acceptable.
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Event Description
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The customer observed lower than expected myoglobin results obtained from a non-vitros quality control (qc) fluid using vitros immunodiagnostic products myoglobin reagent pack on a vitros 5600 integrated system.Biorad level 1 lot 23636 results: 84.36, 82.65, 85.52, 88.75, and 84.44 ng/ml versus customer baseline mean 131 ng/ml.Biased results of the direction and magnitude observed may lead to inappropriate physician action if patient samples were affected and the event were to recur undetected.There was no allegation of patient harm as a result of this event.(b)(4).
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Search Alerts/Recalls
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