MAUDE Adverse Event Report: MAGELLAN DIAGNOSTICS, INC. LEAD ANALYZER SYSTEM; LEAD ANALYZER SYSTEM (PRE-AMENDMENT)

Catalog Number 70-1070-3010B

Device Problem Complete Loss of Power (4015)

Patient Problem No Patient Involvement (2645)

Event Date 08/17/2011

Event Type  malfunction  

Manufacturer Narrative

User facility contacted magellan's product support team to report a burning smell was coming from their 3010b blood lead analyzer.The customer then proceeded to replace the motor on their unit which resolved the issue.No reports of injuries from the user facility.Note: late filing is part of magellan diagnostics, inc.Response to fda's 483 issued on (b)(4) 2017.(b)(4).Customer complaint: (b)(4).

Event Description

User facility contacted magellan's product support team to report a burning electrical smell coming from their lead analyzer system.

• Brand Name: LEAD ANALYZER SYSTEM
• Type of Device: LEAD ANALYZER SYSTEM (PRE-AMENDMENT)
• Manufacturer (Section D): MAGELLAN DIAGNOSTICS, INC.; 101 billerica ave; building 4; n. billerica MA 01862
• Manufacturer (Section G): MAGELLAN DIAGNOSTICS, INC.; 101 billerica ave; building 4; n. billerica MA 01862
• Manufacturer Contact: heather reed ; 101 billerica ave.; building 4; n. billerica, MA 01862 ; 9782484811
• MDR Report Key: 8027098
• MDR Text Key: 127254382
• Report Number: 1218996-2018-00033
• Device Sequence Number: 1
• Product Code: DOF
• UDI-Device Identifier: 00850355006017
• UDI-Public: 00850355006017
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 70-1070-3010B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2011
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1