Catalog Number 07027737190 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/14/2021 |
Event Type
malfunction
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Manufacturer Narrative
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This investigation is ongoing.This event occurred in (b)(6).Unique identifier (udi) #: (b)(4).
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Event Description
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The initial reporter received a questionable elecsys prolactin assay result for one patient with the cobas e 801 module serial number (b)(4) compared to a chemiluminescence method.Note: the units of measure were not provided for the following results.(b)(6).The questionable result was reported outside of the laboratory.It is unclear which result is deemed correct and whether the measurements were performed on the same sample.
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Manufacturer Narrative
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The calibration and qc data were requested but not provided.The investigation found the customer did not perform a polyethylene glycol precipitation (peg) for implausible high samples.Product labeling states: in case of implausible high prolactin values a precipitation by polyethylene glycol (peg) is recommended in order to estimate the amount of the biological active monomeric prolactin.The investigation determined the discrepancy is due to not following recommended procedures.This is considered improper pre-analytical handling by not performing the peg treatment.The investigation did not identify a product problem.
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Search Alerts/Recalls
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