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	09/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported a falsely elevated patient blood lead test result with leadcare ii.Customer reported an elevated leadcare ii pediatric patient blood lead test result of 39.1 ug/dl.Customer reported a secondary edta microtainer device (sarstedt) was used for blood collection.Customer reported a second sample was collected from the patient on the same day using a capillary tube from the leadcare ii blood lead test kit.Customer reported the second sample resulted in a leadcare ii test value of "low" (less than 3.3 ug/dl).Customer reported the corresponding confirmation test result was less than 1.0 ug/dl.Technical services (ts) instructed the customer to only use the capillary tubes for blood collection provided in the leadcare ii blood lead test kit.During troubleshooting ts asked the customer to describe their method for collecting and preparing capillary blood.Customer reported they are not familiar with the procedure.Ts instructed the customer to follow the cdc guidelines for capillary blood lead collection.Ts provided the cdc capillary collection video to the customer.Customer reported level 1 and level 2 controls were within range according to the package insert instructions.Customer did not provide control values.On 16-sep-2026 customer provided details of their leadcare ii testing procedure.Customer described procedures that do not align with the test kit package insert instructions: · not allowing patient's hands to air dry following hand washing.· not avoiding contact with skin while wiping away first drop of blood.· not wiping the outside of capillary tube prior to plunging into the treatment reagent (tr).Regional point of care (rpoc) specialist to conduct retraining with customer.

• 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: 50917384
• Report Number: 1218996-2026-00409
• Device Sequence Number: 14897101
• Product Code: DOF
• UDI-Device Identifier: 00850355006000
• UDI-Public: 00850355006000
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• 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: 2603M-05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2026
• 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