MAUDE Adverse Event Report: MAGELLAN DIAGNOSTICS LEADCARE II ANALYZER

Model Number	LEADCARE II
Medical Device Problem Codes	Bent (1059); Failure to Sense (1559); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A significant number of error messages were generated by the analyzer prior to the complaint, suggesting the analyzer had issues.When the error occurs no results are generated by the instrument.Analyzer was performing as expected by generating those errors, however customer was not running qc according to manufacturer's instructions.No reported harm or injuries occurred as a result of this issue.Corrosion was noted on analyzer 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.Magellan provided the customer with a new instrument, additional training, and additional information on proper analyzer maintenance.No further issues of this nature have been reported by this customer.Late filing is part of magellan diagnostics, inc.Response to fda's 483 issued on 29jun2017.(b)(4).
Event or Problem Description
The analyzer display was changing at inappropriate intervals.This type of error generates no results when it occurs.Customer reported appearance of corrosion of the pins, and one bent pin.Testing of the customer's analyzer at magellan showed all qc results out of range low.Customer was not running periodic qc according to manufacturer's instructions.

• Brand Name: LEADCARE II ANALYZER
• Common Device Name: LEADCARE II
• Manufacturer (Section D): MAGELLAN DIAGNOSTICS; 101 billerica ave; #4; n billerica MA 01862
• MDR Report Key: 7142580
• Report Number: 1218996-2017-00026
• Device Sequence Number: 11072287
• Product Code: DOF
• UDI-Device Identifier: 00850355006178
• UDI-Public: 00850355006178
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Type of Report: Initial
• Report Date (Section B): 12/22/2017

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 Model Number: LEADCARE II
• Device Catalogue Number: 70-6529-R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2017
• Initial Report FDA Received Date: 12/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1