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	01/26/2017
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 continued testing, and was not running periodic qc according to manufacturer's instructions.No reported harm or injuries occurred as a result of this issue.Magellan provided the customer with a new instrument, additional training, sent them notifications.No further issues of this nature have been shown for this customer.(b)(4).
Event or Problem Description
Analyzer would not run when sample was applied to the sensor.Based on troubleshooting over the phone, analyzer error codes were being generated while attempting to run the instrument.The analyzer does not generate results when these types of error codes occur.

• 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: 7142623
• Report Number: 1218996-2017-00028
• Device Sequence Number: 1300910
• Product Code: DOF
• UDI-Device Identifier: 00850355006178
• UDI-Public: 00850355006178
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Physician
• 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: 01/26/2017
• 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