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

Model Number 70-6529

Device Problems Overheating of Device (1437); Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/13/2019

Event Type  malfunction  

Manufacturer Narrative

User facility contacted magellan's product support team to report a user touched the dc part of the ac adaptor and it felt like a "hot cup of soup." during troubleshooting with user, product support (ps) verified there was no batteries installed in the unit.Ps asked if the back of the analyzer was heating up, it was not but it was making a "beeping" noise and the screen was off.Also, user clarified the person affected did not seek medical attention, user stated the person was fine.Ps advised the user to quarantine the instrument and ac adaptor.The instrument, (b)(4), and ac adaptor were returned to magellan.During investigative testing by magellan, ps was able to turn on the instrument with the returned ac adaptor, an in-house ac adaptor, and batteries.The analyzer's main pc board was not electronically damaged.The customer's complaint of the return ac adaptor's dc part heating up was verified during in-house testing.Further tests were performed on the returned ac adaptor.The dc end of the ac adaptor was cut into two halves to identify the short.After separating wires inside, the adaptor was not heating up when plugged into a power supply.No patient impact or harm was reported.(b)(4).

Event Description

User facility contacted magellan's product support team to report a user noted the dc part of the ac adaptor was heating up.

• 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: ivy margaret thiong'o ; 101 billerica ave; building 4; n. billerica, MA 01862 ; 9783135480
• MDR Report Key: 9183727
• MDR Text Key: 195593343
• Report Number: 1218996-2019-00036
• 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: user facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2019
• 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: 70-6529
• Device Lot Number: P8490132A1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Date Manufacturer Received: 09/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2010
• 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