MAUDE Adverse Event Report: MAGELLAN DIAGNOSTICS LEADCARE II

Model Number	LEADCARE II
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	08/08/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The instrument's batteries burned user after the user improperly took the analyzer apart to change the batteries.No medical intervention was necessary or taken.Late filing is part of (b)(6)'s response to fda's 483 issued june 29, 2017.

• Brand Name: LEADCARE II
• Common Device Name: LEADCARE II
• Manufacturer (Section D): MAGELLAN DIAGNOSTICS; 101 billerica ave; building 4; n billerica MA 03064
• MDR Report Key: 6958207
• Report Number: 1218996-2017-00002
• Device Sequence Number: 10949067
• Product Code: DOF
• UDI-Device Identifier: 00850355006178
• UDI-Public: 00850355006178
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 10/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: LEADCARE II
• Device Catalogue Number: 70-6529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2017
• Was the Report Sent to FDA?: No
• Device Age: 9 YR
• Event Location: Outpatient Treatment Facility
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 10/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other