MAUDE Adverse Event Report: Magellan Diagnostics, Inc. LeadCare II Blood Lead Testing System; Blood Lead Test Kit

Catalog Number	70-6762
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported suspected falsely elevated patient blood lead test results with leadcare ii.On (b)(6)2026 the customer reported elevated patient blood lead test results and used sensor error messages with their leadcare ii blood lead test kit.Customer stated they are a manager and was unable to provide additional information at the time of contact.On (b)(6)2026 customer reported an elevated leadcare ii pediatric patient blood lead test result of 4.0 ug/dl.Customer stated the patient was not sent for venous confirmation testing.During troubleshooting technical services (ts) asked the customer to describe their method for collecting and preparing capillary blood.The customer stated they did not have time to describe the testing procedure in depth.Ts briefly reviewed the cdc guidelines for capillary blood lead collection with the customer.Ts provided the customer with the cdc capillary collection video.Ts replaced the customer's leadcare ii blood lead test kit and analyzer due to the used sensor report.On (b)(6)2026 customer stated they would like a follow-up from ts in one month.
Additional Manufacturer Narrative
This customer reported two (2) suspected falsely elevated blood lead test results.This report documents one patient.Separate mdrs are filed for each of the patient results.The related report numbers are referenced in the respective 3500a forms for traceability.

• Brand Name: LeadCare II Blood Lead Testing System
• Common Device Name: Blood Lead Test Kit
• Manufacturer (Section D): Magellan Diagnostics, Inc.; 101 billerica avenue, bldg. 4; north billerica MA 01862
• Manufacturer (Section G): Magellan Diagnostics, Inc.; 101 billerica avenue, bldg. 4; north billerica MA 01862
• Manufacturer Contact: john lewis ; 101 billerica avenue, bldg. 4; north billerica, MA 01862
• MDR Report Key: 50917379
• Report Number: 1218996-2026-00407
• Device Sequence Number: 14897100
• Product Code: DOF
• UDI-Device Identifier: 00850355006000
• UDI-Public: 00850355006000
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K052549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 70-6762
• Device Lot Number: 2613M-01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/21/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown