MAUDE Adverse Event Report: MAGELLAN DIAGNOSTICS, INC. LEADCARE II BLOOD LEAD TEST SYSTEM; LEADCARE II ANALYZER

Catalog Number 70-6529

Device Problem Complete Loss of Power (4015)

Patient Problem No Patient Involvement (2645)

Event Date 09/19/2013

Event Type  malfunction  

Manufacturer Narrative

User facility contacted magellan's product support team to report a burning electrical smell coming from their leadcare ii blood lead testing system when plugged into the a/c adapter and will no longer power on.Unit was returned to magellan for evaluation.During investigational testing the unit would no longer power on, however the returned adapters performed as expected with the manufacturer analyzer.Because the customer indicated a burning smell and the result was total power loss, this is being reported because it has the potential for thermal injury.No report of injuries or erroneous results 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 leadcare ii blood lead testing system when plugged into the a/c adapter.

• Brand Name: LEADCARE II BLOOD LEAD TEST SYSTEM
• Type of Device: LEADCARE II ANALYZER
• 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: 8021159
• MDR Text Key: 125760892
• Report Number: 1218996-2018-00021
• 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: K052549
• 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: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 70-6529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2011
• 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