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

Catalog Number 70-6762

Device Problem False Negative Result (1225)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/23/2012

Event Type  malfunction  

Manufacturer Narrative

User facility called magellan's product support team to report discrepant patient results.A pediatric patient tested on the leadcare ii blood lead testing system and gave a result of 46.3 ug/dl, confirmation testing result was 59 ug/dl.The test kit was not returned for evaluation therefore the cause of the failure can not be determined.No reported harm or injuries occurred as a result of this issue.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 called magellan's product support team to report discrepant patient results.A pediatric patient tested on the leadcare ii blood lead testing system and gave a result of 46.3 ug/dl, confirmation testing result was 59 ug/dl.

• 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: 8027033
• MDR Text Key: 127250764
• Report Number: 1218996-2018-00024
• Device Sequence Number: 1
• Product Code: DOF
• UDI-Device Identifier: 00850355006000
• UDI-Public: 00850355006000
• 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: 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 70-6762
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1