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

Model Number 70-6529

Device Problem Battery Problem (2885)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/30/2016

Event Type  malfunction  

Manufacturer Narrative

There was no device failure reported and the device powered on appropriately.Manufacturer assessment of the returned analyzer indicates batteries ruptured due to the presence of corrosion upon visual inspection.Cause for ruptured batteries could not be determined.No indication of injury or harm to the user.Late filing due to retrospective review on 8nov2019, it was discovered that the original mdr [1218996-2017-00009] (a response to response to fda's 483 issued on 29jun2017) was not submitted.

Event Description

Customer reported that analyzer was leaking clear oily substance out of the battery chamber.Condition continued after changing batteries.No malfunction or user injury reported.

• Brand Name: LEADCARE II BLOOD LEAD TEST SYSTEM
• Type of Device: LEADCARE II ANALYZER
• Manufacturer (Section D): MAGELLAN DIAGNOSTICS, INC.; 101 billerica ave; 101 billerica ave; 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: 9365031
• MDR Text Key: 215262266
• Report Number: 1218996-2019-00040
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/22/2019

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: 70-6529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2016
• Initial Date Manufacturer Received: 08/30/2016
• Initial Date FDA Received: 11/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2014
• 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