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

Model Number 70-6529

Device Problems Electrical /Electronic Property Problem (1198); Electrical Overstress (2924)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/23/2020

Event Type  malfunction  

Manufacturer Narrative

User facility contacted magellan's product support team to report that the user could smell burning rubber coming from the ac adapter.Ps verified that the user did not seek medical attention and stated that no one was burned or hurt.Ps advised the customer to quarantine the instrument, (b)(4) and ac adapter.The customer will return the instrument for further investigation.This report will be updated as needed.(b)(4).

Event Description

User facility contacted magellan's product support team to report the ac adapter smelling like burning rubber.

• 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; north billerica, ma
• Manufacturer (Section G): MAGELLAN DIAGNOSTICS, INC; 101 billerica ave; building 4; north billerica, ma
• Manufacturer Contact: nicole ineson ; 101 billerica ave; building 4; north billerica, ma ; 3135478
• MDR Report Key: 9891539
• MDR Text Key: 195153881
• Report Number: 1218996-2020-00002
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/27/2020

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
• Device Operator: Health Professional
• Device Model Number: 70-6529
• Device Catalogue Number: 70-6760
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2020
• Initial Date FDA Received: 03/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1