MAUDE Adverse Event Report: MAGELLAN DIAGNOSTICS LEADCARE II ANALYZER

Catalog Number	70-652
Medical Device Problem Codes	Failure to Power Up (1476); Temperature Problem (3022)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer called magellan product support to report a power on self-test error.Reboot of the analyzer cleared this error.During call with product support the customer noted that the a/c adapter heated up when the analyzer was powered on.The customer's analyzer and a/c adapter were returned to magellan for further investigation.Based on a preliminary assessment it appeared the power adapter contained a short at the analyzer plug end that resulted in it heating up.The customer had the analyzer and power cord for over 7 years it is unlikely this was a manufacturing defect but rather it is likely the cord was damaged through misuse by a customer (sharp tug on the wire when moving the analyzer, or using the wire to remove the plug instead of the using the overmold and strain relief).Separating the wires at the plug it was discovered there was a damage to the insulation for the ground connection (the wire connected to the barrel).This further confirms that when placed under mechanical/physically stress the analyzer plug will short resulting in the overheating.(b)(4).
Event or Problem Description
Customer called magellan product support to report a power on self-test error.Reboot of the analyzer cleared this error.During call with product support the customer noted that the a/c adapter heated up when the analyzer was powered on.The customer's analyzer and a/c adapter were returned to magellan for further investigation.During in-house investigation of the customer's returned a/c adapter it was noted that it heated up when powering on the analyzer.

• 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: 7643371
• Report Number: 1218996-2018-00009
• Device Sequence Number: 16772405
• Product Code: DOF
• UDI-Device Identifier: 00850355006178
• UDI-Public: 00850355006178
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Medical Technologist
• Type of Report: Initial
• Report Date (Section B): 06/27/2018

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: Medical Technologist
• Device Catalogue Number: 70-652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 06/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1