MAUDE Adverse Event Report: MAGELLAN DIAGNOSTICS LEADCARE II ANALYZER

Catalog Number	70-6529-R
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	10/24/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A significant number of error messages were generated by the analyzer in the month prior to the complaint, indicating the analyzer had issues.When the error occurs no results are generated by the instrument.Analyzer was performing as expected by generating those errors.Corrosion was noted on the 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.Because periodic qc was not being performed according to manufacturer's instructions, the customer was not aware of the change in analyzer performance, if any, prior to the occurrence of error messages.No reported harm or injuries occurred as a result of this issue.(b)(4) provided the customer with a new instrument, additional training, and additional information regarding proper analyzer maintenance.No further issues of this nature have been reported by this customer.Case number: (b)(4).Late filing is part of (b)(4).
Event or Problem Description
Customer called with complaint of used sensor errors.When the error occurs no results are generated by the instrument.Analyzer was performing as expected by generating those errors.The customer was not running qc according to manufacturer's instructions.Customer continue to test patient samples in the presence of recurring error messages.No reported harm or injuries occurred as a result of this issue.

• 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: 7142018
• Report Number: 1218996-2017-00019
• Device Sequence Number: 11046040
• Product Code: DOF
• UDI-Device Identifier: 00850355006178
• UDI-Public: 00850355006178
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional
• 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 Catalogue Number: 70-6529-R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2016
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2016
• 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