MAUDE Adverse Event Report: MAGELLAN DIAGNOSTICS LEADCARE II ANALYZER

Catalog Number	70-6529
Medical Device Problem Codes	Failure to Sense (1559); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Corrosion of the analyzer sensor pins were noted during evaluation of the analyzer, which is the most likely cause of the error messages and failed qc results.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 or when too much sample is added to the test sensor.Per sections 4-8 and 5-8 of the leadcare ii user's manual, " remove the used sensor immediately after recording the result." investigation of the event log showed the customer had been experiencing repeated run-time error messages prior to contacting magellan.(b)(4).
Event or Problem Description
A user facility called magellan's product support on (b)(6) 2018 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 on july 2nd 2018.During investigative testing, magellan observed repeated failed external control tests.Subsequent testing of blood lead level reference standards were all within target ranges.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.There have been no reports of injuries or erroneous results reported by the user facility.

• Brand Name: LEADCARE II ANALYZER
• Common Device Name: LEADCARE II
• Manufacturer (Section D): MAGELLAN DIAGNOSTICS; 101 billerica ave bldg 4; n. billerica MA 01862 1271
• MDR Report Key: 7687680
• Report Number: 1218996-2018-00012
• Device Sequence Number: 756818
• Product Code: DOF
• UDI-Device Identifier: 00850355006178
• UDI-Public: 00850355006178
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K052549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 70-6529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2018
• Initial Report FDA Received Date: 07/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1