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 01/17/2019

Event Type  malfunction  

Manufacturer Narrative

User facility contacted magellan's product support team to report the instrument emitted an electric odor about two weeks prior to reporting the incident to magellan.The primary reporter states they were not involved in the incident, they were informed by the primary user after the fact, therefore, they were unable to provide detail on the origins of the odor.The reporter stated the primary user attempted to power on the instrument once but immediately turned it off after smelling the electric odor.The reporter also stated the facility staff only powers the instrument with the provided leadcare ac adaptor and never uses batteries.The unit was returned to magellan for evaluation.During investigative testing by magellan, it was noted that a voltage regulator was damaged, which is typically attributed to use with an adaptor not compatible with the leadcare analyzer.No user or patient impact or harm was reported.Case number (b)(4).

Event Description

User facility contacted magellan's product support team to report the analyzer emitted an electric odor about two weeks prior to reporting the incident to magellan.The primary reporter states they were not involved in the incident, they were informed by the primary user the day they contacted magellan's product support team.

• 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, ma; building 4; n. billerica MA 01862
• Manufacturer Contact: heather reed ; 101 billerica ave; building 4; n. billerica, MA 01862 ; 9782484811
• MDR Report Key: 8345436
• MDR Text Key: 136615619
• Report Number: 1218996-2019-00004
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 70-6529
• Device Catalogue Number: 70-6529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Date Manufacturer Received: 01/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2011
• 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