A user facility called magellan's product support to report error messages on their leadcare ii analyzer.There was no indication at the time of the report that the analyzer was reporting erroneous results.The analyzer was returned to magellan for evaluation.During investigative testing, magellan observed repeated failed external control tests.A review of the analyzer's event logs showed that the instrument had generated numerous error messages over several months while in use at the user facility but these had not been reported to magellan as specified in product labeling.In addition, the event logs indicate that external qc was not consistently being performed on a monthly basis in accordance with label instructions.Corrosion was noted on sensor pins.Corrosion of the sensor pins occurs when there is overexposure of the analyzer pins to the assay's acidic treatment reagent.This occurs when used test sensors are not removed immediately after testing (per instrument instructions) or when too much sample is added to the test sensor.Periodic testing with blood lead qc controls is used to monitor analyzer performance.Here have been no reports of injuries or erroneous results reported by the user facility.Note: late filing is part of magellan diagnostics, inc.Response to fda's 483 issued on (b)(4) 2017.(b)(4).Customer complaint: (b)(4).
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